Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 35
- Latest Decision
- 2015-12-04
Clearances · page 10 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | MQK | Class II | 2015-12-04 |
| K152904 | SYDNEY IVF EMBRYO BIOPSY MEDIUM | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2015-12-03 |
| K151878 | Video Colposcope | Edan Instruments, Inc. | HEX | Class II | 2015-12-01 |
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | Medgyn Products, Inc. | MQF | Class II | 2015-11-23 |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | HET | Class II | 2015-11-20 |
| K150094 | Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla | Good Clean Love, Inc. | NUC | Class II | 2015-11-19 |
| K151275 | MAKO Device | Nvision Medical | HIH | Class II | 2015-11-13 |
| K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | HIH | Class II | 2015-11-13 |
| K150743 | Water Based Personal Lubricant with Flavours | Karex Industries Sdn. Bhd. | NUC | Class II | 2015-11-12 |
| K150397 | Divine 9 | Carrashield Labs, Inc. | NUC | Class II | 2015-11-09 |
| K150923 | Breast Pump | Guangzhou Jinxinbao Electronic Co., Ltd. | HGX | Class II | 2015-11-06 |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental | Medela AG | HGX | Class II | 2015-11-05 |
| DEN150008 | INVOcell | Invo Bioscience | OYO | Class II | 2015-11-02 |
| K151470 | Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency | First Quality Hygienic, Inc. | HEB | Class II | 2015-11-02 |
| K150153 | Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant | Package Solutions, LLC | NUC | Class II | 2015-10-20 |
| K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | HEW | Class II | 2015-10-13 |
| K151011 | VISERA 4K UHD SYSTEM | Olympus Medical Systems Corp. | HET | Class II | 2015-10-01 |
| K151647 | Uberlube | Uberlube, LLC | NUC | Class II | 2015-09-23 |
| K152440 | Sydney IVF PVP | Willam A. Cook Australia Pty, Ltd. | MQL | Class II | 2015-09-23 |
| K151095 | Circumplast Circumcision Device | Novadien Healthcare | HFX | Class II | 2015-09-18 |
| K143349 | Gynomunal | Polichem S.A | NUC | Class II | 2015-09-16 |
| K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | Smith & Nephew, Inc. | HIH | Class II | 2015-09-02 |
| K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | NUC | Class II | 2015-09-01 |
| K143424 | UTAH CVX-RIPE | Utah Medical Products, Inc. | PFJ | Class II | 2015-08-28 |
| K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2015-08-27 |
| K143529 | UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer | Medline Industries, Inc. | NUC | Class II | 2015-08-21 |
| K150519 | ManipulatOR PRO, ManipulatOR | Gynetech Pty. , Ltd. | LKF | Class II | 2015-08-19 |
| K150857 | Banana Gold | Hankook Latex Gongup Co., Ltd. | HIS | Class II | 2015-08-14 |
| K150398 | EUM 100Pro | Ob Tools, Ltd. | HGM | Class II | 2015-08-06 |
| K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | HIF | Class II | 2015-07-31 |
| K143532 | Durex Silicone | Reckitt Benckiser, LLC | NUC | Class II | 2015-07-31 |
| K142790 | OneTouch Lubricant Gel | Thai Nippon Rubber Industry Co., Ltd. | NUC | Class II | 2015-07-30 |
| K142726 | O Glide Personal Lubricant | Grafenberg Labs | NUC | Class II | 2015-07-24 |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | HEW | Class II | 2015-07-21 |
| K150886 | Trojan Riviera Personal Lubricant | Church & Dwight Co., Inc. | NUC | Class II | 2015-07-20 |
| K143322 | Medline Natural Lubricating Liquid | Medline Industries, Inc. | NUC | Class II | 2015-07-20 |
| K150756 | Micro well group culture dish, 9-well; Micro well group culture dish, 16-well | Hertart | MQK | Class II | 2015-07-20 |
| K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | HGM | Class II | 2015-07-09 |
| K150480 | JO H20 Water Based Personal Lubricant | United Consortium, Inc. | NUC | Class II | 2015-07-08 |
| K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | HEB | Class II | 2015-07-02 |
| K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | HGM | Class II | 2015-07-01 |
| K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | HEB | Class II | 2015-06-23 |
| K150721 | ARDO Calypso Pro Powered Breast Pump | Ardo Medical AG | HGX | Class II | 2015-06-17 |
| K142355 | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | HIR | Class II | 2015-05-28 |
| K143511 | K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant | Reckitt Benckiser | NUC | Class II | 2015-05-20 |
| K141057 | DISPOSABLE CERVICAL BRUSH | Ningbo Hls Medical Products Co., Ltd. | HHT | Class II | 2015-05-14 |
| K143585 | Electric Breast Pump | Shantou Xinghe Electrical Apparatuses Co., Ltd. | HGX | Class II | 2015-05-06 |
| K150615 | Vaginal Moisturizing Gel | Combe Incorporated | NUC | Class II | 2015-05-01 |
| K142926 | iBreastExam | Ue Lifesciences, Inc. | NKA | Class II | 2015-04-23 |
| K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty | Medela AG | HGX | Class II | 2015-04-21 |
| K143574 | Melodi Prime Breast Pump | Genadyne Biotechnologies, Inc. | HGX | Class II | 2015-04-21 |
| K150897 | Tosama 100% Cotton Menstrual Tampon | Tosama, D.O.O. | HEB | Class II | 2015-04-20 |
| K142163 | MALE CIRCUMCISION KITS:RAPIDECLAMP | Medicfit Technology Sdn Bhd | HFX | Class II | 2015-04-20 |
| K143447 | Dilapan-S | Medicem Technology S.R.O | PKN | Class II | 2015-04-17 |
| K142883 | MindChild Meridian M100 Fetal Heart Rate Monitor | Mindchild Medical | HGM | Class II | 2015-04-17 |
| K140506 | JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | NUC | Class II | 2015-04-17 |
| K150072 | TheyFit Male Condom | Theyfit | HIS | Class II | 2015-04-14 |
| K150457 | AlfaSight 9000 Thermographic System | Alfa Thermodiagnostics, Inc. | LHQ | Class I | 2015-04-10 |
| K141913 | PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! | Pjur Group Luxembourg S.A. | NUC | Class II | 2015-04-06 |
| K143695 | CENTRAL MONITORING SYSTEM | Edan Instruments, Inc. | HGM | Class II | 2015-03-30 |
| K140213 | DISPOSABLE ENDOSCOPIC CANNULA | Dongguan Microview Medical Technology Co., Ltd. | HGH | Class II | 2015-03-25 |
| K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | OQY | Class II | 2015-03-25 |
| K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | HIF | Class II | 2015-03-20 |
| K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography Device | Crossbay Medical, Inc. | LKF | Class II | 2015-03-20 |
| K142769 | Fetal Doppler | Icare Newlife Technologies, Inc. | HEK | Class II | 2015-03-20 |
| K143580 | PeriCoach | Analytica, Ltd. | HIR | Class II | 2015-03-18 |
| K143114 | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | LQK | Class II | 2015-03-10 |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | HIH | Class II | 2015-03-09 |
| K141767 | ID MILLENNIUM, ID MOMENTS SILICONE | Westridge Laboratories, Inc. | NUC | Class II | 2015-03-09 |
| K143415 | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | LKF | Class II | 2015-02-26 |
| K142479 | MEGNA BREAST PUMPS | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | HGX | Class II | 2015-02-24 |
| K132220 | PJ'S SERENITY | Limerick, Inc. | HGX | Class II | 2015-02-20 |
| K150147 | Lubrigyn cream | Uniderm Farmaceutici Srl | NUC | Class II | 2015-02-19 |
| K141434 | SATURN 5 LASER | Research Instruments , Ltd. | MRX | Class II | 2015-02-18 |
| K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA | Life Global Group, LLC | MQL | Class II | 2015-02-17 |
| K142716 | VCARE | Conmed Corporation | LKF | Class II | 2015-02-10 |
| K140579 | ULTRASONIC POCKET DOPPLER | Edan Instruments, Inc. | KNG | Class II | 2015-02-06 |
| K141666 | FERTILIGENT SLOW RELEASE IUI CATHETER KIT | Fertiligent, Ltd. | MQF | Class II | 2015-02-03 |
| K142207 | TransferMan 4m Micromanipulator | Eppendorf AG | MQJ | Class II | 2015-01-23 |
| K143498 | LifeGlobal Global HP | Life Global Group, LLC | MQL | Class II | 2015-01-20 |
| K142583 | LaborView LV1000 | Obmedical Company | OSP | Class II | 2015-01-16 |
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | Biofilm, Inc. | PEB | Class II | 2015-01-09 |
| K141515 | AED HYSTEROSCOPE AND ACCESSORIES | National Advanced Endoscopy Devices, Inc. | HIH | Class II | 2015-01-07 |
| K142700 | InsufflatOR Needle | Gynetech Pty. , Ltd. | HIF | Class II | 2014-12-19 |
| K142204 | Bioceptive Suction Cervical Retractor | Bioceptive, Inc. | HDC | Class II | 2014-12-19 |
| K143119 | LT-300 Video Colposcope | Lutech Industries, Inc. | HEX | Class II | 2014-12-18 |
| K140207 | RAPID-I KIT | Vitrolife Sweden AB | MQK | Class II | 2014-12-18 |
| K141893 | VIBRANCE KEGEL DEVICE (VKD) | Bioinfinity (M) Sdn. Bhd. | HIR | Class II | 2014-12-18 |
| K131643 | DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT | Reckitt Benckiser, LLC | NUC | Class II | 2014-12-17 |
| K142164 | MANIPULATOR; MANIPULATOR PRO | Gynetech Pty. , Ltd. | LKF | Class II | 2014-12-17 |
| K132313 | PESSARY | Eis Corporation | HHW | Class II | 2014-12-05 |
| K142168 | NATURE'S BOND 600 AND NATURE'S BOND 603 | Devon Medical Products, Inc. | HGX | Class II | 2014-12-04 |
| K142029 | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | Hologic, Inc. | HIH | Class II | 2014-11-26 |
| K141523 | ALLY UPS | CooperSurgical, Inc. | LKF | Class II | 2014-11-25 |
| K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | Philips Medizin Systeme Boblingen GmbH | HGM | Class II | 2014-11-25 |
| K142147 | EEVA SYSTEM | Auxogyn, Inc. | PBH | Class II | 2014-11-24 |
| K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | HIN | Class II | 2014-11-21 |
| K141194 | FM-3000 FETAL MONITOR | Advanced Instrumentations, Inc. | HGM | Class II | 2014-11-19 |
| K141718 | INTERNAL HYDRATING GEL | Combe Incorporated | NUC | Class II | 2014-11-13 |
| K140193 | DUREX EMBRACE PERSONAL LUBRICANT | Reckitt Benckiser, LLC | NUC | Class II | 2014-11-04 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.