Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 32
- Latest Decision
- 2017-03-07
Clearances · page 9 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K162919 | Male Latex Condoms | Zhejiang Xiangban Latex Products Co., Ltd. | HIS | Class II | 2017-03-07 |
| K162746 | Ontex and other proprietary names | Ontex Bvba | HEB | Class II | 2017-03-03 |
| K161554 | ENDOFLATOR 40, ENDOFLATOR 50 | KARL STORZ Endoscopy-America, Inc. | HIF | Class II | 2017-03-02 |
| K170257 | Sydney IVF Culture Oil | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2017-02-24 |
| K162833 | VitriGuard | Origio A/S | MQK | Class II | 2017-02-16 |
| K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | Biofilm, Inc. | NUC | Class II | 2017-02-10 |
| K163214 | Unicare System, Unicare Manipulator | Clearpath Surgical, Inc. | LKF | Class II | 2017-02-07 |
| K153262 | PUREtrace | Nemo Healthcare BV | OSP | Class II | 2017-02-07 |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Research Instruments Limited | MQH | Class II | 2017-01-23 |
| K163107 | Lifestyles Zero Lubricated Latex Male Condom | Ansell Healthcare Products, LLC | HIS | Class II | 2017-01-23 |
| K162511 | LELO RESPECT HEX Natural Rubber Latex Condom | Lelo, Inc. | HIS | Class II | 2017-01-13 |
| K153128 | Kolplast Cervical Sample Collection Kit | Kolplast CI SA | HHT | Class II | 2017-01-13 |
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | Panpac Medical Corporation | HGH | Class II | 2017-01-13 |
| K161902 | Meridian M110 Fetal Monitoring System | Mindchild Medical | HGM | Class II | 2017-01-12 |
| K162767 | Sentinel BreastScan II System | First Sense Medical, LLC | LHQ | Class I | 2017-01-09 |
| K151857 | Love Alchemy's Love Lotion | Love Alchemy, LLC | NUC | Class II | 2017-01-09 |
| K162064 | CrossBay IVF Embryo Transfer Catheter Set | Crossbay Medical, Inc. | MQF | Class II | 2017-01-05 |
| K161871 | EVA (Enhanced Visual Assessment) System | Mobileodt , Ltd. | HEX | Class II | 2016-12-19 |
| DEN160005 | Hem-Avert Perianal Stabilizer | Stetrix, Inc. | PNU | Class II | 2016-12-19 |
| K162051 | Cryotec | Reprolife, Inc. | MQK | Class II | 2016-12-14 |
| K162648 | U-Blade Veress Needle | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | HIF | Class II | 2016-12-12 |
| K162747 | Proture Double Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | 2016-12-08 |
| K161763 | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device | Smith & Nephew, Inc. | HIH | Class II | 2016-11-22 |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | Medela, Inc. | HGX | Class II | 2016-10-28 |
| K161065 | ColpoWave Colpotomizer and CerviGrip Uterine Manipulator | Surgitools Pty , Ltd. | HEW | Class II | 2016-10-27 |
| K153016 | aoni Natural Rubber Latex Condom | Guangzhou Daming United Rubber Products , Ltd. | HIS | Class II | 2016-10-20 |
| K160864 | Cryotop Vitrification Kit and Cryotop Thawing Kit | Kitazato Biopharma Co., Ltd. | MQL | Class II | 2016-10-07 |
| K160217 | uVue HSG/SHG Catheter | Cook Incorporated | LKF | Class II | 2016-10-06 |
| K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | HEX | Class II | 2016-09-14 |
| K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant | Church & Dwight Co., Inc. | HIS | Class II | 2016-09-09 |
| K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | HGM | Class II | 2016-09-07 |
| K161585 | Mano and Mano Personal Lubricant | Mano and Mano Proprietary Limited | NUC | Class II | 2016-09-06 |
| K160274 | Hi bebe plus | Bistos Co., Ltd. | HGX | Class II | 2016-09-01 |
| K161544 | Trojan Chain Reaction Personal Lubricant | Church & Dwight Co., Inc. | NUC | Class II | 2016-08-31 |
| K161532 | Philips Avent Comfort Single/Twin Electric Breast Pump | Philips Consumer Lifestyle - Innovation Site Eindhoven | HGX | Class II | 2016-08-29 |
| K161545 | Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant | Church & Dwight Co., Inc. | HIS | Class II | 2016-08-26 |
| K161195 | Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) | M3 Global Enterprises, LLC | HIS | Class II | 2016-08-25 |
| K161385 | Just Like Me Personal Lubricant | Wtfn-Dba Classic Erotica/Holiday Products | NUC | Class II | 2016-08-17 |
| K153478 | Sydney IVF Gamete Buffer | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2016-08-15 |
| K161266 | Athena Breast Pump | Exploramed Nc7, Inc. | HGX | Class II | 2016-08-11 |
| K161877 | Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl | First Quality Hygienic, Inc. | HEB | Class II | 2016-08-05 |
| K160664 | Aqueduct 100 Cervical Dilator | Gtimd, LLC | PON | Class II | 2016-08-01 |
| K160863 | PBS(-), Phosphate Buffered Saline | Kitazato Biopharma Co., Ltd. | MQL | Class II | 2016-07-28 |
| K160399 | Skyn Original Polyisoprene Lubricated Male Condom | Ansell Healthcare Products, LLC | MOL | Class II | 2016-07-25 |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | Origio A/S | MQL | Class II | 2016-07-22 |
| K160504 | RI Witness Embryology Heated Plate | Research Instruments Limited | MQG | Class II | 2016-07-18 |
| K153422 | Panpac Disposable Pessary Fitting Set | Panpac Medical Corporation | HHW | Class II | 2016-07-14 |
| K152628 | Pulse H20h! | Toaster Labs, Inc. | NUC | Class II | 2016-07-11 |
| K160758 | PeriCoach OTC | Analytica, Ltd. | HIR | Class II | 2016-07-11 |
| K152671 | Pulse Aloe-ahh | Toaster Labs, Inc. | NUC | Class II | 2016-07-11 |
| K160569 | NeuGuide | Pop Medical Solutions | PBQ | Class II | 2016-07-06 |
| K160644 | Lelo Hex Natural Rubber Latex Condom | Lelo, Inc. | HIS | Class II | 2016-06-30 |
| K153372 | Repagyn vaginal suppositories | Farma-Derma S.R.L. | NUC | Class II | 2016-06-30 |
| K160763 | ally Liquid Personal Lubricant | Private Label Production, LLC | NUC | Class II | 2016-06-29 |
| K152350 | Regular and Special Umbilical Cord Clamp and Cutter | Ningbo Feite Medical Device Co., Ltd. | NBZ | Class II | 2016-06-28 |
| K160511 | Naya Breast Pump System | Naya Health, Inc. | HGX | Class II | 2016-06-24 |
| K152843 | Liger Medical HTU-110 | Liger Medical, LLC | HGI | Class II | 2016-06-24 |
| K153367 | S698 Symbioz flow | Sopro - Acteon Group | HIF | Class II | 2016-06-17 |
| K153607 | ROMA Calculation Tool Using Elecsys Assays | Roche Diagnostics | ONX | Class II | 2016-06-15 |
| K160751 | Symphion Endoscope and Symphion Cervical Sheath | Boston Scientific | HIH | Class II | 2016-06-14 |
| K160717 | ally Warming Liquid Personal Lubricant | Private Label Production, LLC | NUC | Class II | 2016-06-14 |
| K160510 | MAKO 7 | Nvision Medical Corporation | HIH | Class II | 2016-06-09 |
| K152918 | Gun Oil, Pink, Gun Oil H2O, Pink Water | Empowered Products, Inc. | NUC | Class II | 2016-06-02 |
| K160573 | FirstSense Breast Exam | First Sense Medical, LLC | LHQ | Class I | 2016-06-01 |
| K152507 | Dr. Wolff Vagisan Moisturising Cream | Dr. August Wolff GmbH & Co. KG Arzeimittel | NUC | Class II | 2016-05-20 |
| K160090 | Lumipulse G ROMA | Fujirebio Diagnostics,Inc. | ONX | Class II | 2016-05-16 |
| K160380 | LT-300 HD | Lutech Industries, Inc. | HEX | Class II | 2016-05-13 |
| K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2016-05-06 |
| K152682 | Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit | Willian A. Cook Australia Pty, Ltd. | MQL | Class II | 2016-05-05 |
| K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit | Irvine Scientific | MQL | Class II | 2016-05-04 |
| K151502 | ARCHITECT ROMA | Fujirebio Diagnostics,Inc. | ONX | Class II | 2016-04-28 |
| K160211 | Wet Original Personal Lubricant | Trigg Laboratories D/B/A Wet International | NUC | Class II | 2016-04-27 |
| K151357 | MIRI TL | At Medical Uab | MQG | Class II | 2016-04-22 |
| K160814 | Sydney IVF Sperm Cryopreservation Buffer | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2016-04-22 |
| K160142 | MINERAL OIL | Kitazato Biopharma Co., Ltd. | MQL | Class II | 2016-04-21 |
| K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | HGX | Class II | 2016-04-15 |
| K152581 | LifeGlobal Micro Tips | Life Global Group, LLC | MQH | Class II | 2016-04-11 |
| DEN150028 | PneumoLiner | Advanced Surgical Concepts, Ltd. | PMU | Class II | 2016-04-07 |
| K150588 | OVA1 Next Generation | Vermillion, Inc. | ONX | Class II | 2016-03-18 |
| K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | MQK | Class II | 2016-03-14 |
| K152646 | SYLK PERSONAL LUBRICANT | Toro Management, LLC Dba Sylk | NUC | Class II | 2016-03-11 |
| K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | HIF | Class II | 2016-03-04 |
| K152932 | BlastGen | Origio A/S | MQL | Class II | 2016-02-29 |
| K152168 | Love Liquid Personal Lubricant | The Kama Sutra Company | NUC | Class II | 2016-02-05 |
| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | KNG | Class II | 2016-01-29 |
| K151367 | Sydney IVF Hyaluronidase | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2016-01-27 |
| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2016-01-27 |
| K153591 | ebb Complete Tamponade System | Clinical Innovations, LLC | OQY | Class II | 2016-01-14 |
| K151884 | K-Y Marilyn Pleasure Gel | Reckitt Benckiser, LLC | NUC | Class II | 2016-01-11 |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | Cook Incorporated | MQH | Class II | 2016-01-08 |
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant | Laclede, Inc. | NUC | Class II | 2015-12-29 |
| K151567 | ENDOPLUS hand-held laparoscopic instruments | Endoplus | HFI | Class II | 2015-12-23 |
| K150950 | FreezeKit Cleave , ThawKit Cleave | Vitrolife Sweden AB | MQL | Class II | 2015-12-21 |
| K152782 | SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT | William A. Cook Australia Pty. , Ltd. | MQL | Class II | 2015-12-21 |
| K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | LKF | Class II | 2015-12-21 |
| K151284 | Electric Double Breast Pumps | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | HGX | Class II | 2015-12-21 |
| K151413 | Always/Tampax bladder supports | Procter & Gamble | HHW | Class II | 2015-12-18 |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | Cook Incorporated | MQH | Class II | 2015-12-18 |
| K150828 | O-RING Condom | O-Ring Products, LLC | HIS | Class II | 2015-12-18 |
| K152284 | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS | Cotton High Tech S.L. | HEB | Class II | 2015-12-04 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.