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
701–725 of 1727
Cleared Jan 08, 2016
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
K151018 · Cook Incorporated
MQH · Microtools, Assisted Reproduction (pipettes) · 267d
Cleared Dec 21, 2015
FreezeKit Cleave , ThawKit Cleave
K150950 · Vitrolife Sweden AB
MQL · Media, Reproductive · 257d
Cleared Dec 21, 2015
Ally Uterine Positioning System
K153092 · CooperSurgical, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 56d
Cleared Dec 18, 2015
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748 · Cook Incorporated
MQH · Microtools, Assisted Reproduction (pipettes) · 270d
Cleared Dec 01, 2015
Video Colposcope
K151878 · Edan Instruments, Inc.
HEX · Colposcope (and Colpomicroscope) · 145d
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 Nov 13, 2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 52d
Cleared Oct 13, 2015
GelPOINT Transvaginal Access Platform
K143308 · Applied Medical Resources
HEW · Culdoscope (and Accessories) · 329d
Cleared Oct 01, 2015
VISERA 4K UHD SYSTEM
K151011 · Olympus Medical Systems Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 169d
Cleared Sep 02, 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 30d
Cleared Aug 28, 2015
UTAH CVX-RIPE
K143424 · Utah Medical Products, Inc.
PFJ · Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor · 270d
Cleared Aug 21, 2015
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
K143529 · Medline Industries, Inc.
NUC · Lubricant, Personal · 252d
Cleared Jul 21, 2015
CooperSurgical Advincula Delineator Uterine Manipulator
K143650 · CooperSurgical, Inc.
HEW · Culdoscope (and Accessories) · 210d
Cleared Jul 20, 2015
Medline Natural Lubricating Liquid
K143322 · Medline Industries, Inc.
NUC · Lubricant, Personal · 243d
Cleared Jul 01, 2015
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
K150901 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 89d
Cleared Mar 30, 2015
CENTRAL MONITORING SYSTEM
K143695 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 96d
Cleared Feb 26, 2015
Air Bubble Based Infuser (ABBI)
K143415 · CooperSurgical, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 90d
Cleared Feb 10, 2015
VCARE
K142716 · Conmed Corporation
LKF · Cannula, Manipulator/injector, Uterine · 140d
Cleared Feb 06, 2015
ULTRASONIC POCKET DOPPLER
K140579 · Edan Instruments, Inc.
KNG · Monitor, Ultrasonic, Fetal · 337d
Cleared Dec 18, 2014
RAPID-I KIT
K140207 · Vitrolife Sweden AB
MQK · Labware, Assisted Reproduction · 324d
Cleared Nov 26, 2014
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K142029 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 124d
Cleared Nov 25, 2014
ALLY UPS
K141523 · CooperSurgical, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 169d
Cleared Nov 21, 2014
PK Lap Loop
K142525 · Olympus Winter & Ibe GmbH
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 74d
Cleared Oct 23, 2014
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · CooperSurgical, Inc.
HEX · Colposcope (and Colpomicroscope) · 211d
Cleared Aug 25, 2014
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K141294 · Kimberly-Clark Corp.
HEB · Tampon, Menstrual, Unscented · 98d

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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 MQF Catheter, Assisted Reproduction 24 OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 24