Review Panel
Ear, Nose, Throat FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,803
- Product Codes (page)
- 30
- Latest Decision
- 2026-09-23
Clearances · page 1 of 39
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K261637 | Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | 2026-09-23 |
| K261725 | OtoCompanion (Version 1.0) | Ironsides Medical, Inc. | SHL | Class II | 2026-09-21 |
| K260309 | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | EOQ | Class II | 2026-09-16 |
| K254299 | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) | Karl Storz SE & CO. KG | EOB | Class II | 2026-09-15 |
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | Flexicare Medical Limited. | EOQ | Class II | 2026-09-02 |
| K261142 | Ponto 5 Mini; Ponto 5 Superpower | Oticon Medical AB | MAH | Class II | 2026-08-26 |
| K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | Shokz Health Global Limited | LXB | Class II | 2026-08-19 |
| K260266 | Tympendi (810) | Grace Medical, Inc. | KHJ | Class II | 2026-08-18 |
| K260413 | Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation | KLW | Class II | 2026-08-13 |
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | SCR | Class II | 2026-07-31 |
| K260620 | SeptAlign (SPLN001) | Spirair, Inc. | NHB | Class II | 2026-07-30 |
| K260382 | MONARCH Platform (MON-000008) | Auris Health, Inc. | EOQ | Class II | 2026-07-25 |
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | Cook Ireland, Ltd. | KTI | Class II | 2026-07-24 |
| K254296 | Ossiclear (Ossiclear System) | Sounduct | LXB | Class II | 2026-07-22 |
| K254044 | Hearing assist | Meta Platform Technologies, LLC | SCR | Class II | 2026-07-13 |
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System | Cochlear Americas | PFO | Class II | 2026-07-10 |
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | EOQ | Class II | 2026-07-10 |
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix | PDQ | Class II | 2026-06-25 |
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | QUH | Class II | 2026-06-25 |
| K261544 | Hydro Irrigation System | Stryker Instruments | EOB | Class II | 2026-06-17 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation | EOQ | Class II | 2026-06-16 |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | Zdeer Technology (Henan) Co., Ltd. | LXB | Class II | 2026-06-15 |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | LXB | Class II | 2026-06-11 |
| K260614 | Tinnitus Therapy | Sivantos GmbH | KLW | Class II | 2026-06-10 |
| K252624 | KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | EQN | Class II | 2026-05-15 |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | EOQ | Class II | 2026-05-14 |
| K254133 | ENTity USB Videoscope System | Optim, LLC | EOB | Class II | 2026-05-14 |
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations | PDQ | Class II | 2026-04-26 |
| K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | ETD | Class II | 2026-04-23 |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Olympus Medical Systems Corp. | EOQ | Class II | 2026-04-23 |
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | KTI | Class II | 2026-04-16 |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. | EOQ | Class II | 2026-04-08 |
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH | ETA | Class II | 2026-04-03 |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | 2026-04-03 |
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | 2026-04-03 |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd. | EOB | Class II | 2026-03-25 |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | EOB | Class II | 2026-03-20 |
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. | SHL | Class II | 2026-03-17 |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | KTI | Class II | 2026-03-12 |
| DEN250012 | LifeVac | Lifevac, LLC | QXN | Class II | 2026-03-04 |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | EWY | Class II | 2026-03-02 |
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | ETN | Class II | 2026-02-27 |
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | PNZ | Class II | 2026-02-19 |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. | ETN | Class II | 2026-02-10 |
| K251790 | SeptAlign | Spirair, Inc. | NHB | Class II | 2026-01-16 |
| K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | QQH | Class II | 2026-01-09 |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | KTI | Class II | 2025-12-19 |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | EOQ | Class II | 2025-12-12 |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | EOQ | Class II | 2025-12-05 |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | KTI | Class II | 2025-10-08 |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | BWH | Class II | 2025-09-26 |
| K251208 | Tuned Self-Fitting Mobile App | Tuned , Ltd. | SCR | Class II | 2025-09-26 |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | 2025-09-23 |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | EOQ | Class II | 2025-09-23 |
| K252528 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | 2025-09-05 |
| K250874 | Sunrise | Sunrise SA | QRS | Class II | 2025-08-29 |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | EOQ | Class II | 2025-08-27 |
| K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) | Zhejiang UE Medical Corp. | EOQ | Class II | 2025-08-11 |
| K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | EOB | Class II | 2025-08-11 |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corporation | KTI | Class II | 2025-07-29 |
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | 2025-07-25 |
| K243655 | TurbAlign | Spirair, Inc. | LYA | Class I | 2025-07-11 |
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | W&H Dentalwerk Buermoos GmbH | ERL | Class II | 2025-07-03 |
| K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | PDQ | Class II | 2025-06-26 |
| K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | Olympus Medical Systems Corp. | EOQ | Class II | 2025-06-23 |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | Inomed Medizintechnik GmbH | ETN | Class II | 2025-06-13 |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | EOQ | Class II | 2025-06-13 |
| K251279 | Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corporation | BTG | Class II | 2025-06-12 |
| K243639 | Portare System (FA-001) | Grumpy Innovation, Inc. | EOB | Class II | 2025-06-05 |
| K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | EOQ | Class II | 2025-06-04 |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | Olympus Medical Systems Corporation | EOQ | Class II | 2025-05-30 |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear | LXB | Class II | 2025-05-29 |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | Shanghai AnQing Medical Instrument Co., Ltd. | EOQ | Class II | 2025-05-29 |
| K242793 | Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1. | Shenzhen Insighters Medical Technology Co., Ltd. | EOQ | Class II | 2025-05-28 |
| K243541 | LumiRex Bronchoscope | Contra Healthcare Solutions, LLC | EOQ | Class II | 2025-04-30 |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | Aventamed Dac | ETD | Class II | 2025-04-28 |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | LXB | Class II | 2025-04-25 |
| K242214 | Sonu | Sound Health Systems, Inc. | QZC | Class II | 2025-04-24 |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | KTI | Class II | 2025-03-31 |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) | Scivita Medical Technology Co., Ltd. | EOQ | Class II | 2025-03-19 |
| K242010 | Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) | Shenzhen Sanping Image Technology Co., Ltd. | EOQ | Class II | 2025-03-14 |
| K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | KTI | Class II | 2025-03-04 |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | EOB | Class II | 2025-03-03 |
| K242324 | DUTAU-NOVATECH® | Novatech SA | EOQ | Class II | 2025-02-06 |
| K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | SCR | Class II | 2025-01-31 |
| K243219 | MONARCH Platform (MON-000008) | Auris Health, Inc. | EOQ | Class II | 2025-01-23 |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | 2025-01-17 |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | ETA | Class II | 2025-01-17 |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | 2025-01-17 |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | 2025-01-16 |
| K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | EWL | Class II | 2024-12-18 |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | ETN | Class II | 2024-12-13 |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | 2024-10-29 |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | Scivita Medical Technology Co., Ltd. | EOQ | Class II | 2024-10-23 |
| K242070 | Ion Endoluminal System (IF 1000) | Intuitive Surgical, Inc. | EOQ | Class II | 2024-09-24 |
| K234096 | MonoStereo | Medicaltek Co., Ltd. | EOB | Class II | 2024-09-19 |
| DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | SCR | Class II | 2024-09-12 |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | ETN | Class II | 2024-07-31 |
| K241150 | MISTI Silicone Implant | Keosan Trading Co. | MIB | Class II | 2024-07-24 |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Oticon Medical AB | PFO | Class II | 2024-07-10 |
3,803 clearances in the Ear, Nose, Throat panel. Data: openFDA.