Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 30
- Latest Decision
- 2019-07-22
Clearances · page 7 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182817 | CottonDay Tampon | Taebong Co., Ltd. | HEB | Class II | 2019-07-22 |
| K182798 | KIDScore D3 | Vitrolife A/S | PBH | Class II | 2019-07-19 |
| K190575 | iBreastExam | Ue Lifesciences, Inc. | NKA | Class II | 2019-07-16 |
| K190150 | Sage 2-in-1 Personal Lubricant and Moisturizer | Fairhaven Health, LLC | NUC | Class II | 2019-07-16 |
| K182814 | Rael Tampon | Rael, Inc. | HEB | Class II | 2019-07-15 |
| K183050 | GLISSANT Intimate Lubricant | Vjuvenate, LLC | NUC | Class II | 2019-07-08 |
| K190277 | ProVate Vaginal Support | Contipi Medical , Ltd. | HHW | Class II | 2019-07-08 |
| K181672 | SureTouch Mobile Pressure Mapping System | Sure, Inc. | NKA | Class II | 2019-06-28 |
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | Fujifilm Irvine Scientific, Inc. | MQL | Class II | 2019-06-21 |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | MQE | Class II | 2019-06-12 |
| K182749 | Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. | HGX | Class II | 2019-06-12 |
| K190827 | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid | Uvision360, Inc. | HIH | Class II | 2019-06-06 |
| K191335 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | HIH | Class II | 2019-06-06 |
| K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) | Vcomin Technology Limited | KNG | Class II | 2019-05-29 |
| K182975 | MAKO 7 | Boston Scientific Corporation | HIH | Class II | 2019-05-21 |
| K183505 | KY Banksy Moisture | Rb Health (Us), LLC | NUC | Class II | 2019-05-17 |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) | Cook Incorporated | MQF | Class II | 2019-05-17 |
| K190372 | Aveta System | Meditrina, Inc. | HIH | Class II | 2019-05-16 |
| K190639 | Endosee System | CooperSurgical, Inc. | HIH | Class II | 2019-05-15 |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | MQE | Class II | 2019-05-10 |
| K181545 | Hysteroscope System | Shanghai AnQing Medical Instrument Co., Ltd. | HIH | Class II | 2019-05-10 |
| K190218 | Unscented Menstrual Tampon | Qingdao Youjia Hygiene Technology Co., Ltd. | HEB | Class II | 2019-05-09 |
| K190187 | Gynescope System | Illumigyn , Ltd. | HEX | Class II | 2019-05-08 |
| K182585 | JO Actively Trying Personal Lubricant | United Consortium | PEB | Class II | 2019-04-26 |
| K182049 | exCellerator Cervical Collection Device | Excell Company, LLC | HHT | Class II | 2019-04-25 |
| K182100 | Smile Makers Personal Lubricant | Lfbeauty (Thailand) Limited | NUC | Class II | 2019-04-25 |
| K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | HIH | Class II | 2019-04-24 |
| K183584 | JO H2O Jelly Original Personal Lubricant | United Consortium | NUC | Class II | 2019-04-17 |
| K183302 | KY Banksy Aloe | Rb Health (Us), LLC | NUC | Class II | 2019-04-16 |
| K181844 | One Touch | Thai Nippon Rubber Industry Public Company, Ltd. | HIS | Class II | 2019-04-15 |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | LKF | Class II | 2019-03-29 |
| K190303 | AirSeal | Conmed Corporation | HIF | Class II | 2019-03-28 |
| K181716 | InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health | LHQ | Class I | 2019-03-25 |
| K182813 | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | Cotton High Tech S.L. | HEB | Class II | 2019-03-15 |
| K182413 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | 2019-03-07 |
| K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant | United Consortium | NUC | Class II | 2019-03-04 |
| K182710 | Fetal Doppler, Model FD88 | Shenzzhen Luckcome Technology Inc., Ltd. | KNG | Class II | 2019-03-01 |
| K183020 | Endosee System | CooperSurgical, Inc. | HIH | Class II | 2019-01-31 |
| K183468 | Revive Reusable Bladder Support | Rinovum Subsidiary 2, LLC | HHW | Class II | 2019-01-25 |
| K182675 | Polygon Resection Device | Polygon Medical, Inc. | HIH | Class II | 2019-01-04 |
| K181461 | Rapid-i Kit | Vitrolife Sweden AB | MQK | Class II | 2019-01-04 |
| K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control | Interscope, Inc. | PTE | Class II | 2019-01-03 |
| K180014 | Creme de La Femme Feminine Lubricant | Cewal, Inc. Dba Premiere Enterprises | NUC | Class II | 2018-12-21 |
| K180828 | Natureplex Warm Touch Warming Jelly | Natureplex, LLC | NUC | Class II | 2018-12-20 |
| K182190 | Fetal Doppler | Shenzhen AOJ Medical Technology Co., Ltd. | KNG | Class II | 2018-12-19 |
| K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | HIH | Class II | 2018-12-06 |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC | MOL | Class II | 2018-12-06 |
| K181784 | Spectra S3 Plus | Uzinmedicare Co. | HGX | Class II | 2018-11-30 |
| K182764 | Biop Digital Colposcope | Biop Medical , Ltd. | HEX | Class II | 2018-11-27 |
| K182027 | Wet Organics Personal Lubricant | Trigg Laboratories Dba Wet International | NUC | Class II | 2018-11-21 |
| K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant | United Consortium | NUC | Class II | 2018-11-14 |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation | MQK | Class II | 2018-11-09 |
| K181911 | Interlude 100% Cotton Tampon | Albaad Fem | HEB | Class II | 2018-11-02 |
| K173351 | Panpac Flexi Shelf Pessary | Panpac Medical Corporation | HHW | Class II | 2018-10-31 |
| K180735 | Endomat Select | Karl Storz SE & CO. KG | HIG | Class II | 2018-10-31 |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | LKF | Class II | 2018-10-26 |
| K180291 | Cook Silicone Balloon HSG Catheter | Cook Incorporated | LKF | Class II | 2018-10-26 |
| K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter | Cook Incorporated | MQF | Class II | 2018-10-24 |
| K182002 | Cumulus Remover | Kitazato Corporation | MQL | Class II | 2018-10-23 |
| K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | Medela, LLC | HGX | Class II | 2018-10-16 |
| K181863 | Elvie Pump | Chiaro Technology Limited | HGX | Class II | 2018-10-10 |
| K181124 | Acessa ProVu System | Acessa Health, Inc. | HFG | Class II | 2018-09-28 |
| K181034 | Pocket Colposcope System | Hadleigh Health Technologies, LLC | HEX | Class II | 2018-09-21 |
| K181078 | The Sex Gel | Necessaire, Inc. | NUC | Class II | 2018-09-10 |
| K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | HGM | Class II | 2018-09-10 |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | Edan Instruments, Inc. | HGM | Class II | 2018-08-30 |
| K180496 | TruClear Elite Hysteroscope | Covidien | HIH | Class II | 2018-08-29 |
| K180073 | Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set | Shenzhen Vitavitro Bio-Tech Co., Ltd. | MQL | Class II | 2018-08-29 |
| K181408 | JO Classic Hybrid Personal Lubricant | United Consortium | NUC | Class II | 2018-08-27 |
| K181974 | MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. | HIH | Class II | 2018-08-23 |
| K180850 | re.t.a Reuseable Tampon Applicator | Thinx, Inc. | HEB | Class II | 2018-08-20 |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | KNF | Class II | 2018-08-15 |
| DEN170052 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | 2018-08-10 |
| K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | ETHICON, Inc. | PWJ | Class II | 2018-08-10 |
| K180075 | MINUET LCD, MINUET LCD eco | Unimom.Co | HGX | Class II | 2018-08-06 |
| K180825 | Fluent Fluid Management System | Hologic, Inc. | HIG | Class II | 2018-08-03 |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) | Church & Dwight Co., Inc. | NUC | Class II | 2018-08-01 |
| K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole | Corinth Medtech, Inc. | HIH | Class II | 2018-07-25 |
| K180419 | Ultrasonic Doppler (Model YM-2T8) | Shenzhen Imdk Medical Technology Co., Ltd. | KNG | Class II | 2018-07-19 |
| K180552 | Modified Novy Cornual Cannulation Set | Cook Incorporated | MOV | Class II | 2018-07-12 |
| K180923 | Personal Lubricating Jelly | Perrigo New York, Inc. | NUC | Class II | 2018-07-09 |
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | ETHICON, Inc. | PWJ | Class II | 2018-07-06 |
| K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | ETHICON, Inc. | PWJ | Class II | 2018-06-28 |
| K172846 | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | LKF | Class II | 2018-06-26 |
| K172842 | GCE704 Breast Pump | Globalcare | HGX | Class II | 2018-06-18 |
| K173225 | Interlude and private label Unscented 3-piece compact applicator tampon | Albaad Fem | HEB | Class II | 2018-06-15 |
| K172835 | GRI-Alleset Veress Needle | Gri Medical and Electronic Technology Co., Ltd. | HIF | Class II | 2018-06-11 |
| K173070 | HSW Resection Instruments | Henke-Sass, Wolf GmbH | HIH | Class II | 2018-06-08 |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | Genea Biomedx Pty, Ltd. | MQG | Class II | 2018-06-07 |
| K180712 | Coconut Infused Hybrid Personal Lubricant | United Consortium | NUC | Class II | 2018-06-06 |
| K172780 | SD1 Ultrasonic Pocket Doppler | Edan Instruments, Inc. | KNG | Class II | 2018-06-06 |
| K180136 | BioNude Lubricant | Good Clean Love, Inc. | NUC | Class II | 2018-06-01 |
| K180167 | Playtex Stella Tampons | Playtex Manufacturing, Inc. | HEB | Class II | 2018-05-30 |
| K173431 | Towako Transmyometrial Embryo Transfer Set | William A. Cook Australia Pty. , Ltd. | MQF | Class II | 2018-05-18 |
| K173264 | EmbryoScope+ | Vitrolife A/S | MQG | Class II | 2018-05-11 |
| K173901 | MyoSure MANUAL Tissue Removal Device | Hologic, Inc. | HIH | Class II | 2018-05-08 |
| K172661 | Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co. KG | HCZ | Class II | 2018-05-08 |
| K180740 | VitriGuard | Origio A/S | MQK | Class II | 2018-05-04 |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left | Caldera Medical, Inc. | PWJ | Class II | 2018-05-04 |
| K173715 | AlertWatch:OB | Alertwatch, Inc. | HGM | Class II | 2018-04-23 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.