Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 29
- Latest Decision
- 2026-09-25
Clearances · page 1 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | Karl Storz SE & CO. KG | HIH | Class II | 2026-09-25 |
| K254303 | KARL STORZ SUPRALOOP | Karl Storz SE & CO. KG | KNF | Class II | 2026-09-24 |
| K260117 | Everslide | Special Situations, LLC | NUC | Class II | 2026-09-23 |
| K262108 | FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms Aqueous Lubricant (Plain);MO Male Latex Condoms Aqueous Lubricant (Ribbed);MO Male Latex Condoms Aqueous Lubricant (Dotted);MO | Shanghai Personage Hygiene Products Co., Ltd. | HIS | Class II | 2026-09-21 |
| K261102 | UNIDRIVE Select System | Karl Storz SE & CO. KG | HIH | Class II | 2026-09-18 |
| K254203 | Wearable Breast Pump (Model S36) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-09-17 |
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | Zhejiang Geyi Medical Instrument Co., Ltd. | HIH | Class II | 2026-09-08 |
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | Philips Consumer Lifestyle B.V. | HGX | Class II | 2026-09-03 |
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) | Maxigen Biotech, Inc. | NUC | Class II | 2026-09-03 |
| K253673 | Mcare System (MW-20) | Marani Health, Inc. | LQK | Class II | 2026-09-03 |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | 2026-09-01 |
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) | CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. | MQL | Class II | 2026-08-28 |
| K260643 | Cimilre Dual Max | Cimilre Co., Ltd. | HGX | Class II | 2026-08-21 |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | 2026-08-20 |
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) | CooperSurgical, Inc. | MQG | Class II | 2026-08-19 |
| K260209 | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | HIF | Class II | 2026-08-19 |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | Axora Medical, Inc. | HIH | Class II | 2026-08-18 |
| K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | HGM | Class II | 2026-08-10 |
| K261905 | BUM Oil | Bumlicious, LLC (DBA Bumlicious) | NUC | Class II | 2026-08-07 |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-07-24 |
| K253694 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | 2026-07-17 |
| K261706 | Endomat Select (UP220) | KARL STORZ SE & CO. KG | HIG | Class II | 2026-07-16 |
| K253662 | LIXI (LXOSFM1) | Luwi, LLC | MSC | Class II | 2026-07-14 |
| K261199 | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-07-13 |
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | NUC | Class II | 2026-07-09 |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. | NUC | Class II | 2026-07-06 |
| DEN250034 | Claria System | Claria Medical, Inc. | SIM | Class II | 2026-07-02 |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | HGX | Class II | 2026-06-26 |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | HGX | Class II | 2026-06-25 |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology , Ltd. | HIF | Class II | 2026-06-25 |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | NUC | Class II | 2026-06-22 |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-06-18 |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-06-17 |
| K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | MRX | Class II | 2026-06-17 |
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Gimbo Medical Technology Shenzhen Co., Ltd. | MQE | Class II | 2026-06-15 |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | HGX | Class II | 2026-06-12 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | NUC | Class II | 2026-06-11 |
| K250129 | AViTA Breast Pump | Avita Corporation | HGX | Class II | 2026-06-11 |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-06-09 |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. | NUC | Class II | 2026-06-09 |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | HGX | Class II | 2026-06-04 |
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | HIH | Class II | 2026-06-04 |
| K254300 | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited | HGX | Class II | 2026-05-29 |
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | NUC | Class II | 2026-05-21 |
| K254244 | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-05-21 |
| K253911 | Derma-2 | Neko Health AB | LHQ | Class I | 2026-05-20 |
| K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | HIH | Class II | 2026-05-15 |
| K253642 | Jada System (Jada-2002) | Organon, LLC | OQY | Class II | 2026-05-15 |
| K250781 | Embryo Predict | Alife Health | PBH | Class II | 2026-05-15 |
| K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | HGX | Class II | 2026-05-13 |
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | HIS | Class II | 2026-05-04 |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-04-29 |
| K260248 | Ultra-Fast Warm | Kitazato Corporation | MQL | Class II | 2026-04-28 |
| K260194 | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | MQG | Class II | 2026-04-28 |
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | HIR | Class II | 2026-04-27 |
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | HGX | Class II | 2026-04-22 |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | NUC | Class II | 2026-04-16 |
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | HIF | Class II | 2026-04-16 |
| K253510 | Freestyle Mini Hands-free | Medela, LLC | HGX | Class II | 2026-04-10 |
| K260033 | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-04-08 |
| K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-04-08 |
| K253946 | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-04-07 |
| K250208 | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | HGX | Class II | 2026-04-06 |
| K252744 | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co., Ltd. | HGX | Class II | 2026-04-03 |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) | Hudi Pharma Srl | NUC | Class II | 2026-04-01 |
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | MOL | Class II | 2026-03-30 |
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | HIG | Class II | 2026-03-27 |
| K252005 | Livi Device | Liviwell, Inc. | HEB | Class II | 2026-03-20 |
| K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | HGX | Class II | 2026-03-12 |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-03-09 |
| K252208 | JFord Speculum Sleeve | Ford Medtech, LLC | HIB | Class II | 2026-03-06 |
| K253983 | Water-based lubricant | Guangzhou Haoyimai Trading Co., Ltd. | NUC | Class II | 2026-03-06 |
| K260380 | Mendit | Escala Medical, Ltd. | PBQ | Class II | 2026-03-04 |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | HIH | Class II | 2026-02-26 |
| K253021 | ANNE Maternal | Sibel Health, Inc. | HGM | Class II | 2026-02-26 |
| K251687 | Konig Bell Circumcision Clamp | Medline Industries, LP | HFX | Class II | 2026-02-25 |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | Casebioscience, Inc. | MQL | Class II | 2026-02-20 |
| K252420 | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-02-13 |
| K252422 | Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-02-13 |
| K253149 | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | HGX | Class II | 2026-02-13 |
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | Guangzhou Hehong Biotech Co., Ltd. | MQF | Class II | 2026-02-12 |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | HGX | Class II | 2026-02-06 |
| K253498 | Pump In Style® Pro+ | Medela, LLC | HGX | Class II | 2026-01-22 |
| K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes | Cooper Surgical | HHW | Class II | 2026-01-20 |
| K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | KNG | Class II | 2026-01-08 |
| K253072 | Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | HGX | Class II | 2025-12-23 |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC | NUC | Class II | 2025-12-19 |
| K252342 | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | 2025-12-19 |
| K252754 | Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | 2025-12-19 |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) | Jiangsu Jiyuan Medical Technology Co., Ltd. | HIH | Class II | 2025-12-18 |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | HEB | Class II | 2025-12-17 |
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | LKF | Class II | 2025-12-15 |
| K252935 | Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) | Foshan Pingchuang Medical Technology Co., Ltd. | NUC | Class II | 2025-12-15 |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | NUC | Class II | 2025-12-12 |
| K252260 | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. | LKF | Class II | 2025-11-26 |
| K251932 | Spectra Platinum | Uzinmedicare Co., Ltd. | HGX | Class II | 2025-11-25 |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | HIS | Class II | 2025-11-18 |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2025-10-29 |
| K252630 | Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | HGX | Class II | 2025-10-27 |
| K252629 | Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | HGX | Class II | 2025-10-27 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.