Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 28
- Latest Decision
- 2022-02-23
Clearances · page 5 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K212786 | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | HIF | Class II | 2022-02-23 |
| DEN210034 | ONE Male Condom | Global Protection Corp. | QRZ | Class II | 2022-02-23 |
| K210208 | Titan Condoms | Titan Condoms, LLC | HIS | Class II | 2022-02-17 |
| K213647 | Durex Patronus Wide | Rb Health (Us), LLC | HIS | Class II | 2022-02-17 |
| K212180 | Wearable Breast Pump (Model S12) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2022-02-11 |
| K211024 | Electric Breast Pump | Shantou Huihengqi Electronic Technology Co., Ltd. | HGX | Class II | 2022-02-11 |
| K212885 | Actively Trying Personal Lubricant Rose Scented | CC Wellness, LLC | PEB | Class II | 2022-02-11 |
| K212705 | Actively Trying Personal Lubricant Unfragrance | CC Wellness, LLC | PEB | Class II | 2022-02-09 |
| K213311 | Lucy Breast Pump | Willow Innovations, Inc. | HGX | Class II | 2022-02-09 |
| K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium | Shenzhen Vitavitro Biotech Co., Ltd. | MQL | Class II | 2022-02-01 |
| K212884 | Electric breast pump | Dongguan Rongfeng Medical Co., Ltd. | HGX | Class II | 2022-01-20 |
| K212505 | DUMI ManipulatOR | The O R Company Pty, Ltd. | LKF | Class II | 2022-01-10 |
| K211940 | Fetal Doppler | Shenzhen Taikang Medical Equipment Co., Ltd. | KNG | Class II | 2022-01-07 |
| K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla | Ttk Healthcare Limited | HIS | Class II | 2021-12-23 |
| K213207 | Sheath, Stopcock Accessory | Olympus Winter & Ibe GmbH | HIH | Class II | 2021-12-22 |
| K211755 | Electric Breast Pump | Zhejiang Carebao Co., Ltd. | HGX | Class II | 2021-12-01 |
| K211959 | Milli Vaginal Dilator | Materna Medical | HDX | Class II | 2021-12-01 |
| K210095 | Playboy Premium Silicone Lubricant | Thai Nippon Rubber Industry Public Company Limited. | NUC | Class II | 2021-11-23 |
| K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | HIH | Class II | 2021-11-23 |
| K212000 | Medley | Good Clean Love, Inc. | NUC | Class II | 2021-11-18 |
| K212104 | Water-soluble Personal Lubricant | Foshan Pingchuang Medical Technology Co., Ltd. | NUC | Class II | 2021-11-18 |
| K211998 | Desnuda Reflect | Good Clean Love, Inc. | NUC | Class II | 2021-11-18 |
| K212659 | More-Cell-System | Agency For Medical Innovations GmbH | PMU | Class II | 2021-11-10 |
| K211967 | Sensual Massage, Ultra Pure | Dreambrands, Inc. | NUC | Class II | 2021-11-09 |
| K210628 | X-FLO Fluid Management System | Thermedx, LLC | HIG | Class II | 2021-11-04 |
| K212084 | Fetal Doppler | Shenzhen Mericonn Technology Co., Ltd. | KNG | Class II | 2021-11-03 |
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Cotton High Tech S.L. | HEB | Class II | 2021-10-22 |
| K210124 | Synergy Gold (SG) Portable (Models MM011450 and MM011460) | Uzinmedicare Co. | HGX | Class II | 2021-10-19 |
| K202433 | Aqueduct 200 Cervical Dilation Balloon Catheter | Gtimd, LLC | PON | Class II | 2021-10-15 |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | HET | Class II | 2021-10-13 |
| K212479 | Cohitech Reusable Tampon Applicator | Cotton High Tech S.L. | HEB | Class II | 2021-10-08 |
| K210270 | Medical Endoscope Image Processing System | Jiangsu Jiyuan Medical Technology Co., Ltd. | HIH | Class II | 2021-10-01 |
| K212757 | Jada System | Alydia Health | OQY | Class II | 2021-09-30 |
| K211450 | Playboy 3 Contour Condom | Thai Nippon Rubber Industry Public Company Limited. | HIS | Class II | 2021-09-30 |
| K210857 | Personal Lubricant | Shenzhen Huanqiu Xuebao Technology Co., Ltd. | NUC | Class II | 2021-09-24 |
| K210294 | One Touch Spiral Condom | Thai Nippon Rubber Industry Public Company Limited. | HIS | Class II | 2021-09-23 |
| K212655 | Flyte | Pelvital USA, Inc. | HIR | Class II | 2021-09-21 |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | HET | Class II | 2021-09-17 |
| K212272 | Tempo Natural Tampon | Dong-A Pharmaceutical Co., Ltd. | HEB | Class II | 2021-09-17 |
| K211227 | HTx Disposable Hysteroscope System | Acuvu, Inc. | HIH | Class II | 2021-09-15 |
| K212412 | IRIS-XP | Medicore Co., Ltd. | LHQ | Class I | 2021-09-13 |
| K212495 | Leva Pelvic Health System | Renovia, Inc. | HIR | Class II | 2021-09-08 |
| K203536 | Male Latex Condom | Global Protection Corp. | HIS | Class II | 2021-09-03 |
| K201612 | Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 | Viramal Limited | NUC | Class II | 2021-09-02 |
| K202802 | TT Electric Breast Pump, TT Double Electric Breast Pump | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | HGX | Class II | 2021-08-26 |
| K210936 | Elvie Stride | Chiaro Technology Limited | HGX | Class II | 2021-08-25 |
| K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | Conmed Corporation | HIF | Class II | 2021-08-19 |
| K212304 | Callaly Tampliner (super plus absorbency) | Calla Lily Personal Care, Ltd. | HEB | Class II | 2021-08-19 |
| K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | HDC | Class II | 2021-08-17 |
| K211519 | Every Cycle Reusable Tampon Applicator | Cycle, LLC | HEB | Class II | 2021-08-13 |
| K210759 | Solo, Swing Maxi | Medela, LLC | HGX | Class II | 2021-08-11 |
| K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | MSC | Class II | 2021-08-05 |
| K211088 | Grosz Play Feel | Rb Health (Us), LLC | NUC | Class II | 2021-07-09 |
| K203148 | Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | HGX | Class II | 2021-07-08 |
| K210104 | SurroundScope System | 270surgical , Ltd. | HET | Class II | 2021-07-08 |
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Hamilton Thorne, Inc. | MRX | Class II | 2021-07-02 |
| K202897 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | 2021-06-24 |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | KNF | Class II | 2021-06-17 |
| K210814 | Coconu Water Based Personal Lubricant | Coconu, LLC | NUC | Class II | 2021-06-14 |
| K203818 | Replens Long-Lasting Vaginal Moisturizer | Church & Dwight Co., Inc. | NUC | Class II | 2021-06-11 |
| K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit | CC Wellness, LLC | NUC | Class II | 2021-06-10 |
| K211469 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | HEB | Class II | 2021-06-10 |
| K210972 | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two | CC Wellness, LLC | NUC | Class II | 2021-06-10 |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | Allwin Medical Devices, Inc. | MQK | Class II | 2021-06-04 |
| K210025 | INVU by Nuvo | Nuvo- Group , Ltd. | LQK | Class II | 2021-05-28 |
| K203377 | VR101 Lubricating Intravaginal Ring | J3 Bioscience, Inc. | QPD | Class II | 2021-05-20 |
| K202667 | Personal Lubricant Jelly | Nantong Health & Beyond Hygienic Products, Inc. | NUC | Class II | 2021-05-18 |
| K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | Vitrolife Sweden AB | MQL | Class II | 2021-05-14 |
| K201152 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | 2021-05-04 |
| K210242 | Astroglide X Silicone Personal Lubricant | Biofilm, Inc. | NUC | Class II | 2021-04-28 |
| K202915 | IRIS Thermocoagulator and Digital Colposcope | Liger Medical, LLC | HGI | Class II | 2021-04-23 |
| K203570 | Mya Joy PLUS Breast Pump | Ameda, Inc. | HGX | Class II | 2021-04-22 |
| K203644 | Solevy Co. LLC Silicone Based Personal Lubricant | Solevy Co., LLC | NUC | Class II | 2021-04-19 |
| K203654 | Solevy Co. LLC Water-Based Personal Lubricant | Solevy Co., LLC | NUC | Class II | 2021-04-19 |
| K202403 | SKORE (Colors & Flavors), SKORE (Colors) | Ttk Healthcare Limited | HIS | Class II | 2021-04-15 |
| K210764 | Flyte | Pelvital USA, Inc. | HIR | Class II | 2021-04-13 |
| K201903 | Electric breast pump (Models: RH-228 and RH-338) | Cixi Ruihong Electric Appliance Co., Ltd. | HGX | Class II | 2021-04-09 |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Schoelly Fiberoptic GmbH | HET | Class II | 2021-03-12 |
| K202037 | imani i2 | Imani Co. | HGX | Class II | 2021-03-01 |
| K202045 | imani i1 | Imani Co. | HGX | Class II | 2021-02-26 |
| K200527 | pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur | Pjur Group Luxembourg S.A. | NUC | Class II | 2021-02-19 |
| K193330 | Clue Birth Control | Biowink GmbH | PYT | Class II | 2021-02-18 |
| K200675 | Hi bebe super (Models BT-150S and BT-150L) | Bistos Co., Ltd. | HGX | Class II | 2021-02-10 |
| K200731 | pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 | Pjur Group Luxembourg S.A. | NUC | Class II | 2021-01-21 |
| K201922 | Trophikos Vaginal Moisturizer | Trophikos, LLC | NUC | Class II | 2021-01-14 |
| K202017 | Passion Natural Water Based Lubricant | Xr, LLC | NUC | Class II | 2021-01-08 |
| K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | LHQ | Class I | 2021-01-06 |
| K203257 | LUBi Water Based Personal Lubricant | Boya Biotechnology Co., Ltd. | NUC | Class II | 2020-12-23 |
| K200730 | pjur WOMAN Nude pjur med SENSITIVE glide | Pjur Group Luxembourg S.A. | NUC | Class II | 2020-12-17 |
| K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mL | Hertart Aps | MQK | Class II | 2020-12-16 |
| K203383 | Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 | Philips Consumer Lifestyle - Innovation Site Eindhoven | HGX | Class II | 2020-12-15 |
| K201003 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | HEB | Class II | 2020-12-07 |
| K193444 | Vagisan MoistCream Cremolum | Dr. August Wolff GmbH & Co. KG Arzneimittel | NUC | Class II | 2020-12-04 |
| K193285 | V-ONESTEP | Vitromed GmbH | MQL | Class II | 2020-11-20 |
| K192503 | GM501 Wash with Phenol Red and Gentamicin | Hamilton Thorne Incorporated | MQL | Class II | 2020-11-19 |
| K200239 | Astroglide Organix Gel | Biofilm, Inc. | NUC | Class II | 2020-11-13 |
| K200098 | VagiVital Aktivgel | Peptonic Medical AB | NUC | Class II | 2020-11-10 |
| K200672 | Durex Penck Standard, Durex Penck XL | Rb Health (Us), LLC | HIS | Class II | 2020-11-06 |
| K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | PON | Class II | 2020-11-06 |
| K192811 | BenestaTM Tissue Removal Device | Caldera Medical, Inc. | HIH | Class II | 2020-10-23 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.