Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 31
- Latest Decision
- 2018-04-20
Clearances · page 8 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K180304 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | MQG | Class II | 2018-04-20 |
| K180219 | JO H2O Flavored Personal Lubricants | United Consortium | NUC | Class II | 2018-04-20 |
| K172306 | SuperSlyde Personal Lubricant | Icm Pharma Pte, Ltd. | NUC | Class II | 2018-04-19 |
| K180096 | GDT-1000 System | Acuvu, Inc. | HIH | Class II | 2018-04-16 |
| K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | Cook Incorporated | MQF | Class II | 2018-04-13 |
| K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | Cook Incorporated | MQF | Class II | 2018-04-11 |
| K180083 | Silicone Personal Lubricant, ALL-IN-ONE | United Consortium | NUC | Class II | 2018-04-09 |
| K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | HGH | Class II | 2018-04-09 |
| K173699 | The Pump by Babyation | Babyation, LLC | HGX | Class II | 2018-04-04 |
| K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | HIR | Class II | 2018-04-04 |
| K173489 | GYN-Pump PH304 | W.O.M. World of Medicine GmbH | HIG | Class II | 2018-03-28 |
| K172516 | SurgiQuest AIRSEAL iFS System | Conmed Corporation | HIF | Class II | 2018-03-16 |
| K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | HEW | Class II | 2018-03-14 |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant | Church & Dwight Co., Inc. | HIS | Class II | 2018-03-14 |
| K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) | Dxnow, Inc. | MQK | Class II | 2018-03-08 |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) | CooperSurgical, Inc. | MQL | Class II | 2018-03-02 |
| K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) | Origio A/S | MQL | Class II | 2018-03-02 |
| K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | Cook Incorporated | LKF | Class II | 2018-02-15 |
| K173545 | TEMED Gas Diffuser | Temed | HIF | Class II | 2018-02-14 |
| K173527 | Digitex Delivery Device | Coloplast A/S | PWI | Class II | 2018-02-12 |
| K172751 | iVitri Straw | Reprobitech Corp. | MQK | Class II | 2018-02-09 |
| K172504 | Tosama Biobased Applicator Tube Menstrual Tampon | Tosama, D.O.O. | HEB | Class II | 2018-02-09 |
| K173501 | Meridian Vaginal Positioning System (VPS) | Coloplast | PWK | Class II | 2018-02-09 |
| K171516 | Flip Lube | Imquest Biosciences, Inc. | NUC | Class II | 2018-02-05 |
| K172040 | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | HIG | Class II | 2018-02-05 |
| K172796 | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | HET | Class II | 2018-01-18 |
| K171213 | One Touch Condom with Benzocaine | Thai Nippon Rubber Industry Public Company Limited. | HIS | Class II | 2018-01-12 |
| K171625 | Single Lumen Ovum Aspiration Needles | Willian A. Cook Australia Pty, Ltd. | MQE | Class II | 2018-01-12 |
| K173504 | K-Y Silicone | Reckitt Benckiser, LLC | NUC | Class II | 2018-01-12 |
| K172051 | Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter | Cook Incorporated | MQF | Class II | 2018-01-10 |
| K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module | Lina Medical Aps | HIH | Class II | 2018-01-04 |
| DEN160014 | remOVE System | Ovesco Endoscopy AG | QAG | Class II | 2017-12-22 |
| K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | Cook Incorporated | MQF | Class II | 2017-12-21 |
| K172989 | Electric Breast Pump | Joytech Healthcare Co. , Ltd. | HGX | Class II | 2017-12-20 |
| K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | Boston Scientific Corporation | PWJ | Class II | 2017-12-20 |
| K172473 | LifeStyles® SKYN® Intimate Moments Personal Lubricant | Sxwell USA, LLC | NUC | Class II | 2017-12-15 |
| K171611 | Double Lumen Ovum Aspiration Needles | William A. Cook Australia Pty. , Ltd. | MQE | Class II | 2017-12-15 |
| K171748 | Vitrification Kit and Thawing Kit | Kitazato Corporation | MQL | Class II | 2017-12-14 |
| K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | LHQ | Class I | 2017-12-08 |
| K170797 | wettrust D2care | Wettrust Korea Co., Ltd. | NUC | Class II | 2017-12-06 |
| K172067 | One Mum Pumpset | Ardo Medical AG | HGX | Class II | 2017-11-29 |
| K173111 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | HET | Class II | 2017-11-28 |
| K172050 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | MQE | Class II | 2017-11-21 |
| K171044 | Climax Personal Lubricant | Wsm Investment, LLC, Dba Topco Sales | NUC | Class II | 2017-11-21 |
| K171736 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | MQG | Class II | 2017-11-15 |
| K170799 | AP 50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | HIF | Class II | 2017-11-14 |
| K172060 | Capio SLIM Suture Capturing Device | Boston Scientific Corporation | PWI | Class II | 2017-11-03 |
| K172447 | JO Gelato Flavored Personal Lubricants | United Consortium | NUC | Class II | 2017-10-31 |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | Origio A/S | MQL | Class II | 2017-10-13 |
| K172772 | Freemie Independence, Freemie Liberty | Dao Health | HGX | Class II | 2017-10-13 |
| K172414 | JUD custom fit condom | Global Mailer Partners, LLC | HIS | Class II | 2017-10-12 |
| K172118 | U by Kotex Click Unscented Menstrual Tampons | Kimberly-Clark Corporation | HEB | Class II | 2017-10-11 |
| K163183 | Yooeehouse Breast Pump | Nantong Poly Technology Co., Ltd. | HGX | Class II | 2017-10-02 |
| K171440 | Berkeley VC-10 Vacuum Curettage System | Gyrus Acmi | HHI | Class II | 2017-09-29 |
| K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | Genea Biomedx Pty, Ltd. | MQL | Class II | 2017-09-28 |
| K163674 | Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry | Neo Cosmetique | NUC | Class II | 2017-09-22 |
| K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | HIH | Class II | 2017-09-20 |
| K171730 | FuckWater | Non-Friction Products, Inc. | NUC | Class II | 2017-09-07 |
| K171178 | Central Monitoring System | Edan Instruments, Inc. | HGM | Class II | 2017-09-06 |
| K172048 | FluidSmart | Thermedx, LLC | HIG | Class II | 2017-09-05 |
| K171224 | Arctic Sperm Cryopreservation Medium | Irvine Scientific Sales Co., Inc. | MQL | Class II | 2017-08-31 |
| K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Biofilm, Inc. | NUC | Class II | 2017-08-30 |
| K171896 | Feminine Personal Trainer (FPT) | Ralston Group | HIR | Class II | 2017-08-29 |
| K170722 | Moxxly Flow Collection System | Moxxly, Inc. | HGX | Class II | 2017-08-28 |
| K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | Farus, LLC | HGM | Class II | 2017-08-24 |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Ansell Healthcare Products, LLC | MOL | Class II | 2017-08-02 |
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | MOL | Class II | 2017-08-01 |
| K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | HGX | Class II | 2017-07-31 |
| DEN150053 | FETAL PILLOW | Safe Obstetric Systems, Ltd. | PWB | Class II | 2017-07-27 |
| K171855 | External Moisturizing Gel | Combe Incorporated | NUC | Class II | 2017-07-21 |
| K171021 | JO Agapé Personal Lubricant | United Consortium | NUC | Class II | 2017-07-18 |
| K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | MQF | Class II | 2017-07-14 |
| K162878 | Kitazato ET Catheters | Kitazato Corporation | MQF | Class II | 2017-07-13 |
| K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | HIH | Class II | 2017-07-13 |
| K162881 | Kitazato OPU Needles | Kitazato Corporation | MQE | Class II | 2017-07-11 |
| K162640 | iVitri EZ | Reprobitech Corp. | MQK | Class II | 2017-06-30 |
| K162582 | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit | Fisher & Paykel Healthcare | HIF | Class II | 2017-06-23 |
| K161970 | Follicle Aspiration Set | Vitrolife Sweden AB | MQE | Class II | 2017-06-14 |
| K160753 | COOK Vacuum Pump | William A. Cook Australia Pty. , Ltd. | MQG | Class II | 2017-06-13 |
| K162569 | YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer | Biotech Lubricants, Ltd. | NUC | Class II | 2017-06-09 |
| K170681 | Continuous Single Culture -NX (CSCM-NX) | Irvine Scientific Sales Co., Inc. | MQL | Class II | 2017-06-08 |
| K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | HIR | Class II | 2017-06-08 |
| K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) | Irvine Scientific Sales Co., Inc. | MQL | Class II | 2017-06-07 |
| K162409 | Gems Vitrification Set, Gems Warming Set | Genea Biomedx Pty, Ltd. | MQL | Class II | 2017-05-24 |
| K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | HFE | Class II | 2017-05-24 |
| K170446 | LT-300 SD Digital Video Colposcope | Lutech Industries, Inc. | HEX | Class II | 2017-05-21 |
| K171139 | LaparoLight Veress Needle | Buffalo Filter, LLC | HIF | Class II | 2017-05-18 |
| K170784 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | HIF | Class II | 2017-05-15 |
| K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase | Genea Biomedx Pty, Ltd. | MQL | Class II | 2017-05-12 |
| K162667 | Kitazato IUI Catheter | Kitazato Corporation | MQF | Class II | 2017-05-11 |
| K162207 | Restore Moisturizing Vaginal Lubricant | Good Clean Love | NUC | Class II | 2017-05-04 |
| K162319 | BabyDance Fertility Lubricant | Fairhaven Health, LLC | PEB | Class II | 2017-04-28 |
| K170120 | EndoRotor | Interscope, Inc. | PTE | Class II | 2017-04-18 |
| K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit | CooperSurgical, Inc. | MQL | Class II | 2017-04-04 |
| K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component | Cook Incorporated | OQY | Class II | 2017-03-31 |
| K162235 | LUVENA VAGINAL MOISTURIZER & LUBRICANT | Laclede, Inc. | NUC | Class II | 2017-03-24 |
| K163320 | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | HET | Class II | 2017-03-21 |
| K162415 | Spectra 9Plus | Uzinmedicare Company | HGX | Class II | 2017-03-15 |
| K161547 | Transem and EchoGen Embryo Transfer Catheters | Origio A/S | MQF | Class II | 2017-03-09 |
| K162870 | CIMLRE F1 and CIMILRE S3 | Cimilre Co., Ltd. | HGX | Class II | 2017-03-07 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.