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

4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3152 Obstetrics & Gynecology devices
1226–1250 of 3152
Cleared Dec 06, 2010
MEDICON MOGEN CLAMP
K100916 · Medicon EG
HFX · Clamp, Circumcision · 248d
Cleared Nov 10, 2010
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 233d
Cleared Jul 26, 2010
PHILIPS OBTRACEVUE MODEL SW REV. G.00
K100420 · Philips Medizin Systeme Boeblingen GmbH
HGM · System, Monitoring, Perinatal · 160d
Cleared Jun 03, 2010
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
K092667 · Intl., Inc.
MQL · Media, Reproductive · 276d
Cleared Jun 01, 2010
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
K091281 · Procter & Gamble Co.
HEB · Tampon, Menstrual, Unscented · 396d
Cleared Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
K100663 · Boston Scientific Corporation
NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 39d
Cleared Apr 05, 2010
LIFEGLOBAL PROTEIN SUPPLEMENT
K092578 · Intl., Inc.
MQL · Media, Reproductive · 227d
Cleared Mar 24, 2010
GYNCARE MORCELLEX TISSUE MORCELLATOR
K100280 · Ethicon, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 51d
Cleared Mar 12, 2010
VCARE DX
K093556 · Conmed Corporation
LKF · Cannula, Manipulator/injector, Uterine · 115d
Cleared Mar 03, 2010
VIT KIT - FREEZE AND THAW
K093273 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 135d
Cleared Feb 17, 2010
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
K092028 · Philips Medizin Systeme Boeblingen GmbH
HGM · System, Monitoring, Perinatal · 226d
Cleared Dec 23, 2009
RAPID-I
K090832 · Vitrolife Sweden AB
MQK · Labware, Assisted Reproduction · 272d
Cleared Dec 23, 2009
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
K091749 · Kimberly-Clark Corp.
HEB · Tampon, Menstrual, Unscented · 190d
Cleared Nov 10, 2009
BARD SACROCOLPOPEXY GRAFT
K090739 · C.R. Bard, Inc.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 235d
Cleared Sep 29, 2009
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
K092278 · Gyrus Acmi, Inc.
HIH · Hysteroscope (and Accessories) · 63d
Cleared Sep 03, 2009
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
K082939 · Cook Urological, Inc.
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 336d
Cleared May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
K083499 · Coloplast A/S
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 164d
Cleared May 08, 2009
PELVIC FLOOR REPAIR SYSTEM
K091131 · Boston Scientific
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 18d
Cleared Apr 24, 2009
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
K083509 · Intl., Inc.
MQL · Media, Reproductive · 149d
Cleared Apr 02, 2009
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
K090713 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 15d
Cleared Mar 31, 2009
ASCEND
K083722 · Caldera Medical, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 106d
Cleared Mar 30, 2009
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 369d
Cleared Feb 06, 2009
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727 · Vitrolife Sweden AB
MQE · Needle, Assisted Reproduction · 142d
Cleared Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K083839 · C.R. Bard, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 23d
Cleared Jan 07, 2009
NEO-VAGINA SURGERY SET AND ACCESSORIES
K071754 · KARL STORZ Endoscopy-America, Inc.
HDX · Dilator, Vaginal · 559d

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 3152 NUC Lubricant, Personal 228 HET Laparoscope, Gynecologic (and Accessories) 224 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 206 HIS Condom 196 HEB Tampon, Menstrual, Unscented 155 HGM System, Monitoring, Perinatal 154 HIH Hysteroscope (and Accessories) 144 HIF Insufflator, Laparoscopic 131 HIL Tampon, Menstrual, Scented, Scented-deodorized 75 HHD Pad, Menstrual, Unscented 64 LKF Cannula, Manipulator/injector, Uterine 61 HHL Pad, Menstrual, Scented, Scented-deodorized 45 MQK Labware, Assisted Reproduction 43 HIG Insufflator, Hysteroscopic 43