Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 29
- Latest Decision
- 2023-07-14
Clearances · page 4 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K223886 | Wearable Breast Pump (Model S18) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2023-07-14 |
| K221137 | Play and Joy Water-Based Lubricant | Innovemed Bio-Tech Co., Ltd. | NUC | Class II | 2023-07-11 |
| K220646 | Play&Joy InvisiLube Lubricant Capsule | Innovemed Bio-Tech Co., Ltd. | NUC | Class II | 2023-07-10 |
| K230469 | Compact Wearable Pump | Lansinoh Laboratories | HGX | Class II | 2023-06-30 |
| K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | HDX | Class II | 2023-06-27 |
| K230518 | HydraDose Vaginal Suppositories | MD Labs, LLC | NUC | Class II | 2023-06-23 |
| K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | HDR | Class II | 2023-06-23 |
| K222932 | INVOcell Intravaginal Culture System | Invo Bioscience | OYO | Class II | 2023-06-22 |
| K230781 | Belle Sensilube | Rb Health (Us), LLC | NUC | Class II | 2023-06-20 |
| K230776 | Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | Shenzhen Lutejiacheng Technology Co., Ltd. | HGX | Class II | 2023-06-09 |
| K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | HDX | Class II | 2023-06-07 |
| K222606 | V-HYADASE | Vitromed GmbH | MQL | Class II | 2023-05-26 |
| K223329 | Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) | Guangzhou Yongyi Industrial Co., Ltd. | HGX | Class II | 2023-05-26 |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | HIF | Class II | 2023-05-16 |
| K223265 | CryoX Vitrification Freeze Kit / Thaw Kit | Zhejiang Horizon Medical Technology Co., Ltd. | MQL | Class II | 2023-05-11 |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 | CC Wellness, LLC | NUC | Class II | 2023-05-08 |
| K223520 | UNIDRIVE SIII System | Karl Storz-Endoscopy-America, Inc. | HIH | Class II | 2023-04-27 |
| K230590 | ARDO Bellis | Ardo Medical AG | HGX | Class II | 2023-03-30 |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | HIF | Class II | 2023-03-28 |
| K220226 | X-Y Lubricating Jelly | R&R Medical Corporation, Ltd. | NUC | Class II | 2023-03-28 |
| K221965 | FemDx FalloView | Femdx Medsystems, Inc. | MKO | Class II | 2023-03-17 |
| K223084 | MilkMate Breast Pump | Milkmate Products, Inc. | HGX | Class II | 2023-03-16 |
| K223693 | Electric breast pump (model: M5) | Shenzhen Lutejiacheng Technology Co., Ltd. | HGX | Class II | 2023-03-09 |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | Rb Health (Us), LLC | NUC | Class II | 2023-03-07 |
| K222573 | imani i2Plus Breast Pump | Imani Co. | HGX | Class II | 2023-03-03 |
| K220035 | Milli Vaginal Dilator | Materna Medical | HDX | Class II | 2023-02-27 |
| K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | HGM | Class II | 2023-02-13 |
| K221476 | Perifit | X6 Innovations | HIR | Class II | 2023-02-10 |
| K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | Artsmedia Denmark Aps | MQL | Class II | 2023-02-10 |
| K221356 | Wee Bell | Wee Medical | HFX | Class II | 2023-02-02 |
| K223117 | V-SPERM WASH | Vitromed GmbH | MQL | Class II | 2023-01-31 |
| K222567 | Playground For All Love Sesh | Playground For All | NUC | Class II | 2023-01-30 |
| K222901 | EVA15 insufflator | Palliare , Ltd. | HIF | Class II | 2023-01-27 |
| K223866 | Carevix Suction Cervical Stabilizer | Aspivix SA | HDC | Class II | 2023-01-25 |
| K222782 | Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) | Zhejiang Carebao Co., Ltd. | HGX | Class II | 2023-01-13 |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | Kimberly-Clark Corporation | HEB | Class II | 2023-01-06 |
| K222045 | Wearable Breast Pump (Model S1DW) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2023-01-04 |
| K221708 | CIMILRE Free-T2 Plus | Cimilre Co., Ltd. | HGX | Class II | 2022-12-23 |
| K222726 | Smartpump 3.0 Double Electric Breast Pump | Lansinoh Laboratories | HGX | Class II | 2022-12-23 |
| K222798 | Rejoni Intrauterine Catheter | Rejoni, Inc. | LKF | Class II | 2022-12-16 |
| K220010 | Daylily Single Use Sterile Embryo Transfer Catheter | Shanghai Horizon Medical Technology Co., Ltd. | MQF | Class II | 2022-12-16 |
| K220926 | Spectra Wearable | Uzinmedicare Co., Ltd. | HGX | Class II | 2022-12-12 |
| K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | HET | Class II | 2022-12-12 |
| K221598 | Wearable breast pump | Mayborn (Uk) Limited | HGX | Class II | 2022-12-09 |
| K222611 | Male Latex Condoms | Suzhou Colour-Way New Material Co., Ltd. | HIS | Class II | 2022-11-28 |
| K212911 | Konig Mogen Clamp | Medline Industries, Inc. | HFX | Class II | 2022-11-18 |
| K222175 | Bloomi Delight Oil-Based Personal Lubricant | The Bloomi Inc.. | NUC | Class II | 2022-11-15 |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | KNF | Class II | 2022-11-08 |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC | HIS | Class II | 2022-11-07 |
| K221086 | CryoRobot Select System | Tmrw Life Sciences, Inc. | QUJ | Class II | 2022-11-04 |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | Bonraybio Co., Ltd. | MQK | Class II | 2022-10-31 |
| K223064 | ALLY II Uterine Positioning System (UPS) | CooperSurgical, Inc. | LKF | Class II | 2022-10-28 |
| K223098 | Bakri Essential Postpartum Balloon | Cook Incorporated | OQY | Class II | 2022-10-28 |
| K220273 | Onetouch Non-paraben Lubricant Gel | Thai Nippon Rubber Industry Public Company Limited. | NUC | Class II | 2022-10-21 |
| K221576 | Ameda Pearl Electric Breast Pump | Ameda, Inc. | HGX | Class II | 2022-10-12 |
| K222068 | Durex Penck III Regular | Rb Health (Us), LLC | HIS | Class II | 2022-10-12 |
| K221243 | OFNat Lubricant (L15) | Suretex Limited | NUC | Class II | 2022-09-30 |
| K222046 | Unscented Menstrual Tampon | Suzhou Borage Medical Technology Co., Ltd. | HEB | Class II | 2022-09-30 |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | Contec Medical Systems Co.,Ltd | KNG | Class II | 2022-09-28 |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | Church & Dwight Co., Inc. | HIS | Class II | 2022-09-28 |
| K221829 | Wet Flavored Personal Lubricants | Trigg Laboratories, Inc. | NUC | Class II | 2022-09-23 |
| K221908 | JO CUMPLAY Personal Lubricant | CC Wellness, LLC | NUC | Class II | 2022-09-20 |
| K220969 | GelPOINT V-Path Vaginal Access System | Applied Medical Resources Corporation | MOK | Class II | 2022-09-16 |
| K213293 | V-HEPES PLUS | Vitromed Langenfeld | MQL | Class II | 2022-09-14 |
| K221557 | Visera Hysterovideoscope Olympus HYF Type V | Olympus Medical Systems Corporation | HIH | Class II | 2022-09-02 |
| K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | HIS | Class II | 2022-08-05 |
| K221328 | Bloomi Smooth Water Based Lubricant | The Bloomi Inc.. | NUC | Class II | 2022-08-04 |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | Church & Dwight Co., Inc. | HIS | Class II | 2022-07-14 |
| K220534 | Wet Essential95 Personal Lubricant | Trigg Laboratories, Inc. | NUC | Class II | 2022-07-07 |
| K221036 | Astroglide Warming | Biofilm, Inc. | NUC | Class II | 2022-07-01 |
| K213913 | leva Pelvic Health System | Renovia, Inc. | HIR | Class II | 2022-06-30 |
| K211016 | Powered Breast Pump (Models 7V and 7X) | Haenim Co., Ltd. | HGX | Class II | 2022-06-29 |
| K220309 | Wearable Breast Pump (Model S10) | Shenzhen Lutejiacheng Technology Co., Ltd. | HGX | Class II | 2022-06-27 |
| K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | HGM | Class II | 2022-06-23 |
| K213220 | Revaree Plus Vaginal Suppositories | Farma-Derma S.R.L. | NUC | Class II | 2022-06-21 |
| K212426 | Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | MQL | Class II | 2022-06-16 |
| K220420 | Saffron Fixation System | Coloplast A/S | PBQ | Class II | 2022-06-10 |
| K220355 | Astroglide Ultra Gentle Gel | Biofilm, Inc. | NUC | Class II | 2022-05-26 |
| K220596 | Wearable Breast Pump (Model S9) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2022-05-26 |
| K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) | Meditrina, Inc. | HIH | Class II | 2022-05-26 |
| K211152 | Durex Condom with Benzocaine | Rb Health (Us), LLC | HIS | Class II | 2022-05-11 |
| K212564 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | 2022-05-06 |
| K221046 | Invu by Nuvo | Nuvo- Group , Ltd. | LQK | Class II | 2022-05-06 |
| K220653 | Astroglide Glycerin & Paraben Free | Biofilm, Inc. | NUC | Class II | 2022-05-06 |
| K213921 | Microthin Natural Rubber Latex Condom | Suretex Limited | HIS | Class II | 2022-04-28 |
| K212928 | Lorals | Brazen Goods Inc. Dba Lorals | MSC | Class II | 2022-04-22 |
| K212277 | Tempo Tampon | Dong-A Pharmaceutical Co., Ltd. | HEB | Class II | 2022-04-21 |
| K212773 | ARDO Alyssa | Ardo Medical AG | HGX | Class II | 2022-04-15 |
| K212260 | Sensuva Premium Silicone Personal Lubricant | Valencia Naturals, Inc. | NUC | Class II | 2022-04-13 |
| K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | LHQ | Class I | 2022-04-12 |
| K213783 | Apyx | Escala Medical | PBQ | Class II | 2022-04-05 |
| K220202 | Uterine ElevatOR PRO with OccludOR Balloon | The O R Company Pty, Ltd. | LKF | Class II | 2022-03-31 |
| K212037 | SancDam Latex Oral Dam | Sanctuary Health Sdn. Bhd. | MSC | Class II | 2022-03-28 |
| K212955 | Fit Pro Breast Pump | Hygeia II Medical Group, Inc. | HGX | Class II | 2022-03-15 |
| K213869 | EmbryoSlide+ ic8 dish | Vitrolife A/S | MQK | Class II | 2022-03-11 |
| K212965 | Smile-100 System | Niramai Health Analytix Private Limited | LHQ | Class I | 2022-03-10 |
| K213671 | Astroglide Sensual Strawberry Personal Lubricant | Biofilm, Inc. | NUC | Class II | 2022-03-03 |
| K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry | Rb Health (Us) | NUC | Class II | 2022-03-01 |
| K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Cotton High Tech S.L. | HEB | Class II | 2022-02-25 |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | Okamoto USA, Inc. | MOL | Class II | 2022-02-25 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.