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

4478
Total
4465
Cleared
163d
Avg (2y)
1976
Since
849 Obstetrics & Gynecology devices
676–700 of 849
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 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 Jul 14, 2017
Soules Intrauterine Insemination Catheter
K163318 · Cook Incorporated
MQF · Catheter, Assisted Reproduction · 233d
Cleared May 24, 2017
Tao Brush I.U.M.C. Endometrial Sampler
K170603 · Cook Incorporated
HFE · Brush, Endometrial · 84d
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 Nov 20, 2015
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
K150525 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 263d
Cleared Sep 02, 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 30d
Cleared Aug 21, 2015
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
K143529 · Medline Industries, Inc.
NUC · Lubricant, Personal · 252d
Cleared Jul 20, 2015
Medline Natural Lubricating Liquid
K143322 · Medline Industries, Inc.
NUC · Lubricant, Personal · 243d
Cleared Dec 13, 2013
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
K132015 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 165d
Cleared Jun 26, 2013
KSEA BIPOLAR ELECTRODE
K122983 · KARL STORZ Endoscopy-America, Inc.
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 273d
Cleared Dec 18, 2012
UPSYLON Y MESH
K122794 · Boston Scientific Corp
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 97d
Cleared Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
K122459 · Boston Scientific Corporation
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 122d
Cleared Nov 22, 2011
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 118d
Cleared Nov 16, 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · Medline Industries, Inc.
HIF · Insufflator, Laparoscopic · 128d

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All categories 849 HGX Pump, Breast, Powered 128 NUC Lubricant, Personal 117 HIH Hysteroscope (and Accessories) 70 HET Laparoscope, Gynecologic (and Accessories) 59 MQL Media, Reproductive 50 HEB Tampon, Menstrual, Unscented 37 HIF Insufflator, Laparoscopic 37 HIS Condom 30 HGM System, Monitoring, Perinatal 25 MQK Labware, Assisted Reproduction 17 LKF Cannula, Manipulator/injector, Uterine 17 MQF Catheter, Assisted Reproduction 16 HIG Insufflator, Hysteroscopic 15 KNG Monitor, Ultrasonic, Fetal 13 KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories) 11