FDA Review Panel · OB

FDA 510(k) Obstetrics & Gynecology Devices

FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview

FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.

Key categories:

  • Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
  • Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
  • Breast pumps and lactation aids - electric and manual breast pumps
  • Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
  • Pregnancy test systems - hCG detection devices for professional and home use

4499
Total
4485
Cleared
168d
Avg (2y)
1976
Since
1727 Obstetrics & Gynecology devices
676–700 of 1727
Cleared Jan 12, 2018
One Touch Condom with Benzocaine
K171213 · Thai Nippon Rubber Industry Public Company Limited.
HIS · Condom · 262d
Cleared Jan 12, 2018
Single Lumen Ovum Aspiration Needles
K171625 · Willian A. Cook Australia Pty, Ltd.
MQE · Needle, Assisted Reproduction · 224d
Cleared Jan 12, 2018
K-Y Silicone
K173504 · Reckitt Benckiser, LLC
NUC · Lubricant, Personal · 60d
Cleared Jan 10, 2018
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K172051 · Cook Incorporated
MQF · Catheter, Assisted Reproduction · 188d
Cleared Jan 04, 2018
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
K171113 · Lina Medical Aps
HIH · Hysteroscope (and Accessories) · 265d
Cleared Dec 21, 2017
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
K172321 · Cook Incorporated
MQF · Catheter, Assisted Reproduction · 142d
Cleared Dec 15, 2017
Polyform Synthetic Mesh
K171271 · Boston Scientific Corporation
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 228d
Cleared Nov 21, 2017
Follicle Aspiration Set, Reduced Single Lumen
K172050 · Vitrolife Sweden AB
MQE · Needle, Assisted Reproduction · 138d
Cleared Nov 03, 2017
Capio SLIM Suture Capturing Device
K172060 · Boston Scientific Corporation
PWI · Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse · 119d
Cleared Sep 20, 2017
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K172566 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 26d
Cleared Sep 06, 2017
Central Monitoring System
K171178 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 138d
Cleared Aug 31, 2017
Arctic Sperm Cryopreservation Medium
K171224 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 127d
Cleared Jul 14, 2017
Soules Intrauterine Insemination Catheter
K163318 · Cook Incorporated
MQF · Catheter, Assisted Reproduction · 233d
Cleared Jul 13, 2017
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
K170660 · CooperSurgical, Inc.
HIH · Hysteroscope (and Accessories) · 132d
Cleared Jun 14, 2017
Follicle Aspiration Set
K161970 · Vitrolife Sweden AB
MQE · Needle, Assisted Reproduction · 331d
Cleared Jun 08, 2017
Continuous Single Culture -NX (CSCM-NX)
K170681 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 94d
Cleared Jun 07, 2017
Continuous Single Culture-NX Complete (CSCM-NXC)
K170602 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 98d
Cleared May 24, 2017
Tao Brush I.U.M.C. Endometrial Sampler
K170603 · Cook Incorporated
HFE · Brush, Endometrial · 84d
Cleared Apr 04, 2017
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
K170560 · CooperSurgical, Inc.
MQL · Media, Reproductive · 36d
Cleared Mar 31, 2017
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
K170622 · Cook Incorporated
OQY · Intrauterine Tamponade Balloon · 30d
Cleared Mar 02, 2017
ENDOFLATOR 40, ENDOFLATOR 50
K161554 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 269d
Cleared Nov 22, 2016
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 148d
Cleared Oct 07, 2016
PK Morcellator
K161038 · Gyrus Acmi, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 177d
Cleared Oct 06, 2016
uVue HSG/SHG Catheter
K160217 · Cook Incorporated
LKF · Cannula, Manipulator/injector, Uterine · 251d
Cleared Jun 14, 2016
Symphion Endoscope and Symphion Cervical Sheath
K160751 · Boston Scientific
HIH · Hysteroscope (and Accessories) · 88d

Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.

Search all Obstetrics & Gynecology 510(k) devices

Filter by Product Code

All categories 1727 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 MQL Media, Reproductive 121 NUC Lubricant, Personal 121 HIH Hysteroscope (and Accessories) 106 HEB Tampon, Menstrual, Unscented 100 HGM System, Monitoring, Perinatal 86 HIF Insufflator, Laparoscopic 80 HHD Pad, Menstrual, Unscented 54 LKF Cannula, Manipulator/injector, Uterine 43 HHL Pad, Menstrual, Scented, Scented-deodorized 38 HIS Condom 37 HIG Insufflator, Hysteroscopic 27 OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 24 HIL Tampon, Menstrual, Scented, Scented-deodorized 24