Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 29
- Latest Decision
- 2020-10-23
Clearances · page 6 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K200249 | Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) | Kitazato Corporation | MQL | Class II | 2020-10-23 |
| K202799 | EVA15 | Palliare , Ltd. | HIF | Class II | 2020-10-21 |
| K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium | Shenzhen Vitavitro Biotech Co., Ltd. | MQL | Class II | 2020-10-16 |
| K200114 | Astroglide Organix Liquid | Biofilm, Inc. | NUC | Class II | 2020-10-13 |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | HIH | Class II | 2020-10-08 |
| K201381 | Philips Avent Single/Double electric breast pump Advanced | Philips Consumer Lifestyle - Innovation Site Eindhoven | HGX | Class II | 2020-10-01 |
| K202542 | Allura Vaginal Stent | Pmt Corporation | KXP | Class II | 2020-09-30 |
| K201756 | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent | Stryker Sustainability Solutions | HIH | Class II | 2020-09-25 |
| K190798 | LaborView LV1000 Wireless Electrode System | Obmedical Company | OSP | Class II | 2020-09-18 |
| K193449 | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | 2020-09-11 |
| K192822 | Benesta Hysteroscope | Caldera Medical, Inc. | HIH | Class II | 2020-09-09 |
| K201199 | Jada System | Alydia Health | OQY | Class II | 2020-08-28 |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | Kitazato Corporation | MQL | Class II | 2020-08-25 |
| K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | HIR | Class II | 2020-08-24 |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | HET | Class II | 2020-08-21 |
| K193578 | Non-spermicidal Lubricated Male Latex Condom | Global Protection Corp. | HIS | Class II | 2020-08-20 |
| K192845 | Sperm Freeze, Sperm Fridge | Kitazato Corporation | MQL | Class II | 2020-08-17 |
| K201067 | CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) | Cupid Limited | HIS | Class II | 2020-08-07 |
| K201952 | CrossGlide ETS Plus | Crossbay Medical | HHK | Class II | 2020-08-05 |
| K201186 | KY Grosz Jelly | Rb Health (Us), LLC | NUC | Class II | 2020-07-30 |
| K201361 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | HIF | Class II | 2020-07-29 |
| K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. | HIS | Class II | 2020-07-24 |
| K193450 | Pre-Seed Fertility Lubricant | Church & Dwight Co., Inc. | PEB | Class II | 2020-07-23 |
| K193520 | EVA 15 Insufflator | Palliare , Ltd. | HIF | Class II | 2020-07-23 |
| K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | HIG | Class II | 2020-07-22 |
| K200680 | Synvitro Hyadase | Origio A/S, A Coopersurgical Company | MQL | Class II | 2020-07-17 |
| K200409 | Pelvital System | Pelvital USA, Inc. | HIR | Class II | 2020-07-10 |
| K200894 | Agape Cooling Personal Lubricant | CC Wellness, LLC | NUC | Class II | 2020-07-02 |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | Allwin Medical Devices, Inc. | MQF | Class II | 2020-07-01 |
| K200815 | VitriGuard | Origio A/S | MQK | Class II | 2020-06-25 |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | HGM | Class II | 2020-06-24 |
| K200508 | Pump In Style | Medela, LLC | HGX | Class II | 2020-06-15 |
| DEN200026 | EndeavorRx | Akili Interactive Labs, Inc. | QFT | Class II | 2020-06-15 |
| K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant | CC Wellness, LLC | NUC | Class II | 2020-06-03 |
| K192779 | Bunny Wax Personal Lubricant | Reoxcyn, LLC | NUC | Class II | 2020-06-02 |
| K200457 | Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming | CC Wellness, LLC | NUC | Class II | 2020-05-22 |
| K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | HEW | Class II | 2020-05-21 |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | KNF | Class II | 2020-05-04 |
| K192540 | Kitazato ET Catheters | Kitazato Corporation | MQF | Class II | 2020-05-01 |
| K200208 | Agape Warming Personal Lubricant | CC Wellness, LLC | NUC | Class II | 2020-04-27 |
| K192644 | GM501 SpermAir and GM501 SpermActive | Hamilton Thorne Incorporated | MQL | Class II | 2020-04-23 |
| K193032 | KY Grosz Liquid | Rb Health (Us), LLC | NUC | Class II | 2020-04-20 |
| K200712 | Rumble Tuff Electric Breast Pump | A Cute Baby, Inc. | HGX | Class II | 2020-04-17 |
| K192982 | KY Grosz UltraGel | Rb Health (Us), LLC | NUC | Class II | 2020-04-14 |
| K191654 | SILICONE Personal Lubricant | Bath Concept Cosmetics (Dongguan) Co., Ltd. | NUC | Class II | 2020-04-14 |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | HET | Class II | 2020-04-03 |
| K192640 | Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump | Guangzhou Yongyi Industrial Co., Ltd. | HGX | Class II | 2020-03-30 |
| K191401 | PregSense | Nuvo- Group , Ltd. | LQK | Class II | 2020-03-27 |
| K192008 | LaserShot M, NaviLase | Vitrolife GmbH | MRX | Class II | 2020-03-25 |
| K192534 | CrossBay Endometrial Tissue Sampler (ETS) | Crossbay Medical | HHK | Class II | 2020-03-25 |
| K200406 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | HGX | Class II | 2020-03-18 |
| K193448 | BioNourish Lubricant | Good Clean Love, Inc. | NUC | Class II | 2020-03-12 |
| K192898 | PneumoLiner | Advanced Surgical Concepts | PMU | Class II | 2020-02-25 |
| K192557 | Youjia Unscented Tampon with Plastic Applicators | Qingdao Youjia Hygiene Technology Co., Ltd. | HEB | Class II | 2020-02-13 |
| K192203 | JO for Him H2O Gel Original Personal Lubricant | United Consortium | NUC | Class II | 2020-02-10 |
| K191411 | Ah!Yes Ob Coco Personal Lubricant | Bio-Tech Lubricants, Ltd. | NUC | Class II | 2020-02-06 |
| K200038 | Endosee System | CooperSurgical, Inc. | HIH | Class II | 2020-02-05 |
| K193339 | GTK Veress Needles | Guangzhou T.K Medical Instrument Co., Ltd. | HIF | Class II | 2020-01-30 |
| K192146 | V-DENUPET | Vitromed GmbH | MQH | Class II | 2020-01-28 |
| K191109 | Spectra Q | Uzinmedicare Co. | HGX | Class II | 2020-01-22 |
| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | Lina Medical Aps | HIH | Class II | 2020-01-17 |
| K191538 | Resectr Tissue Resection Device | Boston Scientific Corporation | HIH | Class II | 2020-01-16 |
| K191802 | Electric Breast Pump | Ningbo Huiyoo Baby Products Co., Ltd. | HGX | Class II | 2020-01-16 |
| K191020 | G210 InviCell Plus with SignipHy pH monitoring | CooperSurgical, Inc. | PUB | Class II | 2020-01-14 |
| K191052 | HyaloGYN Vaginal Moisturizing Suppositories | Fidia Farmaceutici S.P.A. | NUC | Class II | 2020-01-09 |
| K191666 | Unscented W long plastic and cardboard applicator tampons | Ontex Bvba | HEB | Class II | 2019-12-20 |
| K192100 | Aveta Disposable Hysteroscope | Meditrina, Inc. | HIH | Class II | 2019-12-19 |
| K190752 | Satisfaite | Femmepharma Consumer Healthcare, LLC | NUC | Class II | 2019-12-13 |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | Allwin Medical Devices, Inc. | MQE | Class II | 2019-11-25 |
| K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | HIR | Class II | 2019-11-22 |
| K192204 | Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, | Valencia Naturals, Inc. | NUC | Class II | 2019-11-19 |
| K190797 | Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) | Reed Medical (Zhejiang) Co., Ltd. | HIH | Class II | 2019-11-18 |
| K191110 | HeraBEAT US | Heramed, Ltd. | KNG | Class II | 2019-11-14 |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) | Allwin Medical Devices, Inc. | MQF | Class II | 2019-11-14 |
| K190872 | BioGenesis Fertility Lubricant | Good Clean Love, Inc. | PEB | Class II | 2019-11-07 |
| K192278 | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) | Uvision360, Inc. | HIH | Class II | 2019-11-01 |
| K190190 | WV1 Endoscope | 270surgical , Ltd. | HET | Class II | 2019-11-01 |
| K191264 | Every Second Matters-Uterine Balloon Tamponade (ESM-UBT) | Ujenzi Charitable Trust | OQY | Class II | 2019-10-30 |
| K190465 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | HGX | Class II | 2019-10-18 |
| K191653 | Freestyle Flex | Medela AG | HGX | Class II | 2019-10-17 |
| K191208 | Spectra Cashmere | Uzinmedicare Co. | HGX | Class II | 2019-10-11 |
| K191480 | Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) | Trigg Laboratories, Inc. D/B/A Wet International | NUC | Class II | 2019-10-11 |
| K191431 | Interlude Rolled Tampons in Plastic Applicator | Albaad Fem | HEB | Class II | 2019-10-07 |
| K191958 | Aveta System | Meditrina, Inc. | HIH | Class II | 2019-10-01 |
| K190199 | SepaSperm Washing Solution, SepaSperm Solution | Kitazato Corporation | MQL | Class II | 2019-09-26 |
| K190323 | Aloe Glide Lubricant | Desert Harvest, Inc. | NUC | Class II | 2019-09-25 |
| K191552 | GM501 Mineral Oil | Hamilton Thorne, Inc. | MQL | Class II | 2019-09-18 |
| K190858 | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant | United Consortium | NUC | Class II | 2019-09-18 |
| K191577 | Willow Wearable Breast Pump 2.0 | Exploramed Nc7, Inc. | HGX | Class II | 2019-09-06 |
| K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | HEW | Class II | 2019-09-06 |
| K190383 | GM501 Wash | Hamilton Thorne, Inc. | MQL | Class II | 2019-09-05 |
| K190810 | OPERA, OPERA eco | Unimom.Co | HGX | Class II | 2019-08-30 |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | HET | Class II | 2019-08-29 |
| K191281 | Omni Hysteroscope, Omni Lok cervical seal | Hologic, Inc. | HIH | Class II | 2019-08-29 |
| K191780 | AP50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | HIF | Class II | 2019-08-28 |
| K182142 | FEMME Applicator Tampon | Jiangsu Yoai Technology Co., Ltd. | HEB | Class II | 2019-08-28 |
| K191063 | 1-Step Culture Medium | Shenzhen Vitavitro Biotech Co., Ltd. | MQL | Class II | 2019-08-23 |
| K190813 | CrossBay Cervical Dilator Catheter System | Crossbay Medical | PON | Class II | 2019-08-23 |
| K191214 | JO Premium Jelly Original Personal Lubricant | United Consortium | NUC | Class II | 2019-08-01 |
| K183486 | RapidVit Oocyte, RapidWarm Oocyte | Vitrolife Sweden AB | MQL | Class II | 2019-07-26 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.