FDA Product Code
FDA Product Code LFL — Clearance Directory
- Device Class
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- Assigned Panel
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510(k) Clearances — 158 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | 2026-07-30 | Traditional | PDF ↗ |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2025-10-08 | Traditional | PDF ↗ |
| K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45) | Shanghai Saints Sages Surgical Co., Ltd. | 2025-06-18 | Traditional | PDF ↗ |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments | 2025-03-24 | Traditional | PDF ↗ |
| K241700 | Tenex 2nd Generation System | Trice Medical, Inc. | 2024-11-18 | Traditional | PDF ↗ |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2024-07-11 | Traditional | PDF ↗ |
| K233036 | Ultrasonic Surgical System | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2024-06-18 | Traditional | PDF ↗ |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2023-07-11 | Traditional | PDF ↗ |
| K231117 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC, A Bioventus Company | 2023-06-23 | Special | PDF ↗ |
| K221790 | HARMONIC 700 Shears | Ethicon Endo-Surgery, LLC | 2023-02-28 | Traditional | PDF ↗ |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | Stryker Corporation | 2023-02-16 | Traditional | PDF ↗ |
| K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | Sra Developments, Ltd. | 2022-12-15 | Traditional | PDF ↗ |
| K210567 | Ultrasonic Surgical System | Miconvey Technologies Co., Ltd. | 2022-09-30 | Traditional | PDF ↗ |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2022-08-22 | Traditional | PDF ↗ |
| K221235 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2022-07-28 | Traditional | PDF ↗ |
| K212614 | Ultrasonic Scalpel System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2022-07-18 | Traditional | PDF ↗ |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2022-07-15 | Special | PDF ↗ |
| K212049 | Oclet TDS 1000 | Tendonova Corporation | 2022-03-08 | Traditional | PDF ↗ |
| K213824 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2022-02-03 | Special | PDF ↗ |
| K212060 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2021-12-13 | Traditional | PDF ↗ |
| K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | Covidien, LLC | 2021-11-15 | Traditional | PDF ↗ |
| K212750 | Ultrasonic Surgical Aspirator System, Model: XD880B | Smtp Technology Co., Ltd. | 2021-09-27 | Special | PDF ↗ |
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021-08-04 | Traditional | PDF ↗ |
| K202299 | Ultrasonic Surgical Aspirator System | Smtp Technology Co., Ltd. | 2021-05-21 | Traditional | PDF ↗ |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | Ethicon Endo-Surgery, LLC | 2021-05-21 | Special | PDF ↗ |
| K200427 | Sonicision Cordless Ultrasonic Dissector | Covidien, LLC | 2020-07-10 | Special | PDF ↗ |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020-06-23 | Traditional | PDF ↗ |
| K192963 | Kogent Torus Ultrasonic Aspirator | Katalyst Surgical, LLC | 2020-06-19 | Traditional | PDF ↗ |
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | Ethicon Endo-Surgery, LLC | 2020-02-28 | Traditional | PDF ↗ |
| K190281 | Ultrasonic Surgical System | Medisonic Technology CO | 2019-10-31 | Abbreviated | PDF ↗ |
| K190160 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2019-05-30 | Traditional | PDF ↗ |
| K190070 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2019-04-11 | Traditional | PDF ↗ |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2019-04-01 | Traditional | PDF ↗ |
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2018-12-07 | Traditional | PDF ↗ |
| K181367 | Tenex Health TX System with the TXP MicroTip | Tenex Health, Inc. | 2018-08-28 | Traditional | PDF ↗ |
| K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide | Covidien, LLC | 2018-03-26 | Traditional | PDF ↗ |
| K172691 | Ultrasonic Generator | Olympus Medical Systems Corp. | 2017-10-04 | Special | PDF ↗ |
| K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2017-09-28 | Special | PDF ↗ |
| K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2016-10-14 | Traditional | PDF ↗ |
| K160752 | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length | Ethicon Endo-Suregery, LLC | 2016-06-29 | Traditional | PDF ↗ |
| K153371 | Sonicision Cordless Ultrasonic Dissection Device | Covidien, LLC | 2016-03-28 | Traditional | PDF ↗ |
| K151136 | HARMONIC HOOK | Ethicon Endo-Surgery, LLC | 2016-03-04 | Traditional | PDF ↗ |
| K153299 | Tenex Health TX System | Tenex Health, Inc. | 2016-03-03 | Traditional | PDF ↗ |
| K150682 | CUSA Excel+ | Integra Lifesciences Corp. | 2015-12-18 | Traditional | PDF ↗ |
| K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Sra Developments, Ltd. | 2015-07-17 | Special | PDF ↗ |
| K151340 | HARMONIC Focus Long Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2015-07-10 | Special | PDF ↗ |
| K150271 | Prime Adaptive Ultrasonic Scalpel System | Endoprime, Inc. | 2015-05-29 | Traditional | PDF ↗ |
| K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Integra LifeSciences Corporation | 2014-11-06 | Traditional | PDF ↗ |
| K141668 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Integra LifeSciences Corporation | 2014-11-06 | Traditional | PDF ↗ |
| K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR | Covidien, Formerly Valleylab, A Division of Tyco H | 2014-08-07 | Special | PDF ↗ |
| K132522 | HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | Ethicon Endo-Surgery, LLC | 2013-12-16 | Traditional | PDF ↗ |
| K133314 | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY | Ethicon Endo-Surgery, LLC | 2013-12-03 | Traditional | PDF ↗ |
| K132512 | HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | Ethicon Endo-Surgery, LLC | 2013-10-24 | Special | PDF ↗ |
| K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE | Ethicon Endo-Surgery, LLC | 2013-10-17 | Traditional | PDF ↗ |
| K123640 | TX1 TISSUE REMOVAL SYSTEM | Tenex Health | 2013-03-20 | Traditional | PDF ↗ |
| K121550 | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY | Ethicon Endo-Surgery, LLC | 2012-08-22 | Traditional | PDF ↗ |
| K120729 | HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 | Ethicon Endo-Surgery, LLC | 2012-05-17 | Traditional | PDF ↗ |
| K113570 | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP | Integra Burlington Ma, Inc. | 2012-02-22 | Traditional | PDF ↗ |
| K111741 | INTEGRA(TM) CUSA NXT(TM) BONE TIPS | Integra Burlington Ma, Inc. (Formerly Integra Radi | 2011-08-23 | Traditional | PDF ↗ |
| K102258 | CUSA NXT EXTENDED LENGTH TIP | Integra Radionics, Inc. | 2011-06-10 | Traditional | PDF ↗ |
| K101797 | SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T | Covidien, Formerly Valleylab, A Division of Tyco | 2011-02-24 | Traditional | PDF ↗ |
| K101561 | TX1 TISSUE REMOVAL SYSTEM | American Optisurgical, Inc. | 2010-08-27 | Traditional | PDF ↗ |
| K100597 | HARMONIC FOCUS SHEARS | Ethicon Endo-Surgery, LLC | 2010-04-07 | Traditional | PDF ↗ |
| K090864 | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Integra Radionics, Inc. | 2009-05-08 | Traditional | PDF ↗ |
| K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM | Integra Radionics, Inc. | 2008-08-13 | Traditional | PDF ↗ |
| K072904 | SONOCA 180/195 WOUND CARE SYSTEM | Soering GmbH | 2008-05-21 | Traditional | PDF ↗ |
| K072203 | HARMONIC 10CM COMBINATION HOOK BLADE | Ethicon Endo-Surgery, LLC | 2007-09-25 | Traditional | PDF ↗ |
| K071669 | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP | Integra Radionics, Inc. | 2007-08-17 | Traditional | PDF ↗ |
| K070360 | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 | Kirwan Surgical Products, Inc. | 2007-08-07 | Traditional | PDF ↗ |
| K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Misonix, Inc. | 2007-05-11 | Special | PDF ↗ |
| K063531 | SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM | Sra Developments, Ltd. | 2007-02-22 | Traditional | PDF ↗ |
| K063192 | HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP | Ethicon Endo-Surgery, LLC | 2007-01-30 | Traditional | PDF ↗ |
| K062544 | AR1000 ULTRASONIC WOUND THERAPY SYSTEM | Arobella Medical, LLC | 2007-01-03 | Traditional | PDF ↗ |
| K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF | Misonix, Inc. | 2006-10-26 | Traditional | PDF ↗ |
| K062000 | HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH | Ethicon Endo-Surgery, Inc. | 2006-09-25 | Traditional | PDF ↗ |
| K060245 | HARMONIC SCALPEL BLADES AND SHEARS | Ethicon Endo-Surgery, Inc. | 2006-04-07 | Traditional | PDF ↗ |
| K053056 | HARMONIC SCALPEL BLADES AND SHEARS | Ethicon Endo-Surgery, Inc. | 2006-01-19 | Traditional | PDF ↗ |
| K051947 | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE | Radionics, A Division of Tyco Healthcare Group LP | 2005-08-22 | Traditional | PDF ↗ |
| K050776 | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Misonix, Inc. | 2005-06-06 | Traditional | PDF ↗ |
| K050885 | OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG | Olympus Medical Systems Corporation | 2005-06-03 | Traditional | PDF ↗ |
| K051036 | HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P | Ethicon Endo-Surgery, Inc. | 2005-06-02 | Traditional | PDF ↗ |
| K042160 | SONOSURG TROCAR | Aomori Olympus Co., Ltd. | 2005-01-25 | Traditional | PDF ↗ |
| K042777 | HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P | Ethicon Endo-Surgery, Inc. | 2004-12-01 | Traditional | PDF ↗ |
| K042277 | SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM | Integra Neurosciences, Ltd. | 2004-09-29 | Traditional | PDF ↗ |
| K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | Aomori Olympus Co., Ltd. | 2004-09-08 | Traditional | PDF ↗ |
| K032424 | LOTUS | Sra Developments, Ltd. | 2003-12-16 | Traditional | PDF ↗ |
| K032690 | MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Misonix, Inc. | 2003-12-09 | Traditional | PDF ↗ |
| K032066 | SONOSURG SYSTEM | The Olympus Optical Co. | 2003-10-03 | Traditional | PDF ↗ |
| K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Aomori Olympus Co., Ltd. | 2003-10-01 | Traditional | PDF ↗ |
| K031305 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Olympus Optical Co., Ltd. | 2003-09-23 | Traditional | PDF ↗ |
| K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Aomori Olympus Co., Ltd. | 2003-08-29 | Traditional | PDF ↗ |
| K021962 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | The Olympus Optical Co. | 2003-02-12 | Traditional | PDF ↗ |
| K021989 | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 | Integra Neurosciences | 2002-09-13 | Traditional | PDF ↗ |
| K021929 | AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM | Axya Medical, Inc. | 2002-09-10 | Traditional | PDF ↗ |
| K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE | Synergetics, Inc. | 2002-08-23 | Traditional | PDF ↗ |
| K012753 | SORING GMBH SONOCA 180/190 | Soring GmbH Medizintechnik | 2001-11-13 | Traditional | PDF ↗ |
| K012176 | ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 | Ethicon Endo-Surgery, Inc. | 2001-10-01 | Traditional | PDF ↗ |
| K012028 | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 | Misonix, Inc. | 2001-07-27 | Special | PDF ↗ |
| K010898 | ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 | Ethicon Endo-Surgery, Inc. | 2001-05-31 | Traditional | PDF ↗ |
| K010637 | SONOTOME ULTRASONIC ASPIRATOR TIPS | Synergetics, Inc. | 2001-04-20 | Traditional | PDF ↗ |
Product code LFL · · Unknown. Data: openFDA.