Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 30
- Latest Decision
- 2025-10-22
Clearances · page 2 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251977 | electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | HGX | Class II | 2025-10-22 |
| K251882 | Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) | HHK | Class II | 2025-10-16 |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | HEB | Class II | 2025-10-09 |
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) | Clinical Innovations, LLC | HDB | Class II | 2025-10-08 |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. | HEW | Class II | 2025-10-02 |
| K251512 | Hi bebe super (BT-150B) | Bistos Co., Ltd. | HGX | Class II | 2025-09-25 |
| K250388 | ENDOFLATOR + | Karl Storz SE & CO. KG | HIF | Class II | 2025-09-22 |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | HGM | Class II | 2025-09-19 |
| K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | HEB | Class II | 2025-09-19 |
| K251377 | Magic InBra | Medela AG | HGX | Class II | 2025-09-18 |
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | MQL | Class II | 2025-09-12 |
| K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) | Shenzhen Yongquan Medical Devices Co., Ltd. | NUC | Class II | 2025-09-09 |
| K251394 | Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2025-09-08 |
| K251754 | Wearable Breast Pump (Model S33) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-09-08 |
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | HET | Class II | 2025-08-29 |
| K243799 | Fetal Pillow | CooperSurgical, Inc. | PWB | Class II | 2025-08-29 |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | HGM | Class II | 2025-08-27 |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | MQL | Class II | 2025-08-27 |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | MQL | Class II | 2025-08-26 |
| K250383 | Wearable Breast Pump (Model W6) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-08-20 |
| K243851 | CHLOE BLAST | Fairtility , Ltd. | PBH | Class II | 2025-08-15 |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | HEB | Class II | 2025-08-13 |
| K252192 | Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | HGX | Class II | 2025-08-13 |
| K250207 | eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) | Anker Innovations Limited | HGX | Class II | 2025-08-11 |
| K250142 | Water-based Lubricant | Global Protection Corp. | NUC | Class II | 2025-08-08 |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | NUC | Class II | 2025-08-08 |
| K250843 | Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-07-31 |
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) | Vitrolife Sweden AB | MQF | Class II | 2025-07-23 |
| K252012 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | HIH | Class II | 2025-07-18 |
| K250350 | Thrive 2-in-1 Breast Pump (Model P3) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-07-15 |
| K250034 | Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. | HIS | Class II | 2025-07-11 |
| K250838 | Denudation Pipettes | Guangzhou Pinzhi Medical Device Co., Ltd. | MQH | Class II | 2025-07-03 |
| K242846 | Doppler FHR Detector (BF-500D+, BF-560) | Shenzhen Bestman Instrument Co., Ltd. | KNG | Class II | 2025-06-26 |
| K243729 | Prismira | Lumos Labs, Inc. | QFT | Class II | 2025-06-13 |
| K242712 | LubriZenzs | Sk Zen, LLC | NUC | Class II | 2025-06-04 |
| K243382 | RZ Resectoscope System | Rz Medizintechnik GmbH | HIH | Class II | 2025-06-03 |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV | MQL | Class II | 2025-05-30 |
| K250368 | Wearable Breast Pump (Model S21) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-05-30 |
| K250365 | Motif Aura Glow breast pump (Model Motif Aura Glow) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-05-30 |
| K242725 | Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | HGX | Class II | 2025-05-30 |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | HFN | Class II | 2025-05-22 |
| K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | MQG | Class II | 2025-05-22 |
| K243107 | Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. | NUC | Class II | 2025-05-09 |
| K250629 | Sutil Rich Personal Lubricant | Hathor Professional Skincare , Ltd. | NUC | Class II | 2025-05-02 |
| K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | HET | Class II | 2025-04-25 |
| K243508 | Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-04-21 |
| K250829 | Lacevo Wearable Breast Pump (Model S70) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-04-17 |
| K250212 | LapBox Power Tissue Containment System | Ark Surgical | PMU | Class II | 2025-04-15 |
| K242772 | AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. | HIF | Class II | 2025-04-11 |
| K250438 | CooperSurgical Milex® Pessaries | CooperSurgical, Inc. | HHW | Class II | 2025-04-11 |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. | MQL | Class II | 2025-04-10 |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | MQL | Class II | 2025-04-10 |
| K243967 | ONE Nitrile Condom | Global Protection Corp. | MOL | Class II | 2025-04-08 |
| K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | HDR | Class II | 2025-04-02 |
| K250152 | eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-04-02 |
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | KNF | Class II | 2025-04-02 |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. | HEB | Class II | 2025-04-01 |
| K250561 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | 2025-03-21 |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. | MQL | Class II | 2025-03-21 |
| K241833 | V-GRAD | Vitromed GmbH | MQL | Class II | 2025-03-21 |
| K250463 | Ameda GLO Wearable Breast Pump (Model W8S) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-03-20 |
| K242958 | Joylux Intimacy Gel (PG3100) | Joylux, Inc. | NUC | Class II | 2025-03-20 |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. | HIS | Class II | 2025-03-07 |
| K241617 | Durex Polyisoprene Condom | Rb Health (Us), LLC | MOL | Class II | 2025-02-28 |
| K242850 | Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2025-02-21 |
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. | HIS | Class II | 2025-02-21 |
| K241626 | SperSort Sperm Sorting Chip (IPG02) | Ipreg Incorporation | MQK | Class II | 2025-02-20 |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | HIS | Class II | 2025-02-18 |
| K242111 | VIVACE | Unimom.Co | HGX | Class II | 2025-02-06 |
| K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | Guangzhou Hehong Biotech Co., Ltd. | MQK | Class II | 2025-02-03 |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | HGM | Class II | 2025-02-03 |
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps | MQK | Class II | 2025-01-31 |
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) | Hathor Professional Skincare , Ltd. | NUC | Class II | 2025-01-21 |
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | HGP | Class II | 2025-01-17 |
| K243527 | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation | HIF | Class II | 2025-01-13 |
| K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | HEB | Class II | 2025-01-10 |
| K241009 | PeriCALM Patterns 3.0 | Perigen, Inc. | HGM | Class II | 2025-01-10 |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | 2025-01-08 |
| K241680 | Momcozy Wearable Breast Pump (BP311) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2024-12-20 |
| K243629 | Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430) | Shenzhen Root Innovation Technology Co., , Ltd. | HGX | Class II | 2024-12-20 |
| K241322 | Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) | Joytech Healthcare Co. , Ltd. | HGX | Class II | 2024-12-19 |
| K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | MQL | Class II | 2024-12-18 |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps | MQL | Class II | 2024-12-18 |
| K240798 | Cntrl+ Bladder Support Pessary | Cntrl+, Inc. | HHW | Class II | 2024-12-17 |
| K242645 | INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant | Project Chemistry, Inc. | NUC | Class II | 2024-12-06 |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | 2024-11-22 |
| K242002 | FemVue MINI Saline-Air Device | Femasys, Inc. | LKF | Class II | 2024-11-22 |
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | Shenzhen Vitavitro Biotech Co., Ltd. | MQE | Class II | 2024-11-15 |
| K240218 | Electric Breast Pump (F5055) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | HGX | Class II | 2024-10-17 |
| K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | Li Medical Corporation , Ltd. | LKF | Class II | 2024-10-16 |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | HIF | Class II | 2024-10-15 |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. | MOL | Class II | 2024-10-08 |
| K242125 | Elvie Stride 2 | Chiaro Technology, Ltd. | HGX | Class II | 2024-09-27 |
| K240745 | ID Free Personal Lubricant | Westridge Laboratories, Inc. | NUC | Class II | 2024-09-27 |
| K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | MQK | Class II | 2024-09-26 |
| K240434 | RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) | Li Medical Corporation , Ltd. | HHK | Class II | 2024-09-25 |
| K242162 | Coconut Hybrid | Good Clean Love, Inc. | NUC | Class II | 2024-09-19 |
| K240176 | V-VITFREEZE and V-VITWARM | Vitromed GmbH | MQL | Class II | 2024-09-13 |
| K241004 | Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | HGX | Class II | 2024-09-11 |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | LKF | Class II | 2024-09-06 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.