Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 29
- Latest Decision
- 2024-08-30
Clearances · page 3 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231969 | BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) | Dongguanshi Yiyingmei Technology Co., Ltd. | HGX | Class II | 2024-08-30 |
| K233846 | Vitrification Solution Set and Warming Solution Set | Ecmpc, LLC | MQL | Class II | 2024-08-27 |
| K240896 | ONE Nitrile Condom | Global Protection Corp. | MOL | Class II | 2024-08-23 |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | Shenzhen Vitavitro Biotech Co., Ltd. | MQF | Class II | 2024-08-16 |
| K240081 | Human Lubricant | Jiangxi Wulinxiang Biological Technology Co., Ltd. | NUC | Class II | 2024-08-16 |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | MacroLux Medical Technology Co., Ltd. | HIH | Class II | 2024-08-16 |
| K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | HDX | Class II | 2024-08-14 |
| K240595 | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | HFE | Class II | 2024-08-14 |
| K240605 | Ultra RapidWarm Blast | Vitrolife Sweden AB | MQL | Class II | 2024-08-07 |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Guangzhou Red Pine Medical Instrument Co., Ltd. | HIH | Class II | 2024-08-02 |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | HIR | Class II | 2024-08-01 |
| K240401 | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) | Origyn Medical Technology (Hangzhou) Co., Ltd. | HIH | Class II | 2024-07-26 |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Hologic, Inc. | HIG | Class II | 2024-07-25 |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | KNF | Class II | 2024-07-17 |
| K241705 | MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) | Milkmate Products, Inc. | HGX | Class II | 2024-07-12 |
| K241006 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | 2024-07-11 |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH | HGM | Class II | 2024-07-02 |
| K240536 | Wearable Breast Pump (Model S32) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2024-07-01 |
| K233477 | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) | Shandong Wego Ruisheng Medical Device Co., Ltd. | MQL | Class II | 2024-07-01 |
| K233823 | Ultrasonic Fetal Doppler | Shenzhen Jamr Technology Co., Ltd. | KNG | Class II | 2024-06-28 |
| K241506 | Annabella Double Breast Pump (ADO-US23-1000) | Annabella Tech | HGX | Class II | 2024-06-27 |
| K233361 | Sunny Cup and Applicator | Menstrual Mates | HHE | Class II | 2024-06-21 |
| K233043 | Smart Scope® CX | Periwinkle Technologies Pvt., Ltd. | HEX | Class II | 2024-06-14 |
| K233496 | EndeavorOTC | Akili Interactive Labs, Inc. | QFT | Class II | 2024-06-14 |
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | Contec Medical Systems Co.,Ltd | KNG | Class II | 2024-06-14 |
| K240002 | G-Vitri Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | MQK | Class II | 2024-06-14 |
| K240149 | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | 2024-06-13 |
| K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Select Labs, LLC | NUC | Class II | 2024-06-07 |
| K232774 | Wearable Breast Pump,Model S18 | Ningbo Dearevery Electronic Technology Co., Ltd. | HGX | Class II | 2024-06-06 |
| K232677 | Reia pessary | Reia, LLC | HHW | Class II | 2024-05-21 |
| K232525 | Yoni.Fit Bladder Support | Watkins-Conti Products, Inc. | HHW | Class II | 2024-05-17 |
| K233913 | Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308) | Aoj Health Technology Co., Ltd. | HGX | Class II | 2024-05-14 |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | 2024-05-10 |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. | HEB | Class II | 2024-05-10 |
| K232477 | Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | HGX | Class II | 2024-05-09 |
| K232470 | Polyisoprene Extra Large Condom | Suretex Limited | MOL | Class II | 2024-05-09 |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. | MQG | Class II | 2024-05-07 |
| K232902 | EVA15 insufflator | Palliare , Ltd. | HIF | Class II | 2024-05-02 |
| K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | HIF | Class II | 2024-05-02 |
| K233689 | Hope&Her Vaginal Dilators | Lujena, Inc. | HDX | Class II | 2024-05-02 |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | Fujifilm Irvine Scientific | MQL | Class II | 2024-04-24 |
| K232060 | TOSAMA Reusable Applicator | Tosama, D.O.O. | HEB | Class II | 2024-04-12 |
| K232608 | Duo Hands-free Breast Pump | Medela, LLC | HGX | Class II | 2024-04-12 |
| K233548 | Uresta® | Resilia, Inc. | HHW | Class II | 2024-04-03 |
| K232047 | VIVACE | Unimom.Co | HGX | Class II | 2024-03-28 |
| K232125 | V-PVP | Vitromed GmbH | MQL | Class II | 2024-03-20 |
| K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | MQK | Class II | 2024-03-14 |
| K233136 | Hygeia Express Powered Breast Pump | Hygeia II Medical Group, Inc. | HGX | Class II | 2024-03-13 |
| K233177 | Nest VT Vitrification Device | Cook Incorporated | MQK | Class II | 2024-03-08 |
| K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2024-03-06 |
| K231786 | Gynethotics Pessary | Cosm Medical | HHW | Class II | 2024-03-06 |
| K231260 | HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology Co., Ltd. | HIH | Class II | 2024-03-05 |
| K232040 | Gynatrof | Tyros Biopharma, Inc. | NUC | Class II | 2024-03-01 |
| K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle | Zhejiang Horizon Medical Technology Co., Ltd. | MQE | Class II | 2024-02-22 |
| K231875 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | HIR | Class II | 2024-02-22 |
| K233635 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | HIH | Class II | 2024-02-12 |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | HIH | Class II | 2024-02-12 |
| K232942 | G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | 2024-01-30 |
| K231785 | Perifit Pump | X6 Innovations | HGX | Class II | 2024-01-26 |
| K232466 | Electric Breast Pump, model: YM-8166 | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | 2024-01-19 |
| K233710 | Symphion Operative Hysteroscopy System | Minerva Surgical, Inc. | PGT | Class II | 2024-01-17 |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | HIF | Class II | 2024-01-12 |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | HIR | Class II | 2023-12-29 |
| K231794 | Elegant Advanced CompHort | Viramal Limited | NUC | Class II | 2023-12-22 |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | KNF | Class II | 2023-12-21 |
| K232579 | Twoplus Applicator | Hannah Life Technologies Pte , Ltd. | QYZ | Class II | 2023-12-21 |
| K231780 | Perifit Care+ | X6 Innovations | HIR | Class II | 2023-12-20 |
| K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | HEB | Class II | 2023-12-15 |
| K232401 | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | HIF | Class II | 2023-12-14 |
| K231645 | PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. | QYZ | Class II | 2023-12-14 |
| K231337 | EndeavorRx | Akili Interactive Labs, Inc. | QFT | Class II | 2023-12-13 |
| K231964 | Novii+ Wireless Patch System | Datex Ohmeda | HGM | Class II | 2023-12-08 |
| K232093 | Woo More Play Coconut Love Oil | Woo Essentials, Inc. | NUC | Class II | 2023-12-01 |
| K233500 | Benesta Tissue Removal Device | Caldera Medical, Inc. | HIH | Class II | 2023-11-30 |
| K231203 | Mosie Baby Kit | Mosie Baby | QYZ | Class II | 2023-11-29 |
| K230849 | ELLAVI UBT | Sinapi Biomedical (Pty) , Ltd. | OQY | Class II | 2023-11-13 |
| K230481 | Evenflo Premium Double Electric Breast Pump (Model 4018) | Evenflo Feeding, Inc. | HGX | Class II | 2023-11-03 |
| K231908 | 45 Micron Polyisoprene Condom | Suretex Limited | MOL | Class II | 2023-10-27 |
| K231595 | Electric Breast Pump | Shenzhen Changkun Technology Co., Ltd. | HGX | Class II | 2023-10-26 |
| K232091 | JO Coconut Hybrid Cooling Personal Lubricant | CC Wellness, LLC | NUC | Class II | 2023-10-22 |
| K230570 | Willow Generation 3 Breast Pump | Willow Innovations, Inc. | HGX | Class II | 2023-10-16 |
| K232090 | JO Coconut Hybrid Warming Personal Lubricant | CC Wellness, LLC | NUC | Class II | 2023-10-11 |
| K232279 | LifeStyles NRL Textured Condom | Suretex Limited | HIS | Class II | 2023-10-05 |
| K231730 | FemaSeed Intratubal Insemination | Femasys, Inc. | MQF | Class II | 2023-09-22 |
| K230102 | Smart double sides wearable breast pump, Electric bilateral breast pump | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | HGX | Class II | 2023-09-21 |
| K230239 | AirSeal iFS System; AirSeal dV Solution | Conmed Corporation | HIF | Class II | 2023-09-20 |
| K231342 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | HIF | Class II | 2023-09-20 |
| K223885 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | HIH | Class II | 2023-09-14 |
| K232462 | ThermPix Thermovisual Camera | Usa Therm, Inc. | LHQ | Class I | 2023-09-14 |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT | Ttk Healthcare Limited | HIS | Class II | 2023-09-07 |
| K231407 | StarFin | Premium Medical Technology, LLC | HIF | Class II | 2023-08-29 |
| K231274 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | 2023-08-24 |
| K223813 | Aveta System 2.0 | Meditrina, Inc. | HIH | Class II | 2023-08-21 |
| K223883 | Daye Tampon | Annes Daye, Ltd. | HEB | Class II | 2023-08-18 |
| K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | HEB | Class II | 2023-08-14 |
| K223519 | Carex Hybrid Personal Lubricant | Karex Industries Sdn. Bhd. | NUC | Class II | 2023-08-11 |
| K230672 | Annabella Breast Pump | Annabella , Ltd. | HGX | Class II | 2023-08-04 |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | MQL | Class II | 2023-08-04 |
| K230419 | Sequel Tampon with Plastic Applicator | Tampro, Inc. | HEB | Class II | 2023-08-03 |
| K230730 | Apyx | Escala Medical | PBQ | Class II | 2023-07-25 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.