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
776–800 of 1727
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 Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
K100663 · Boston Scientific Corporation
NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 39d
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 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 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
Cleared Dec 23, 2008
ENDOSCOPIC CO2 REGULATION UNIT UCR
K081173 · Olympus Medical Systems Corporation
HET · Laparoscope, Gynecologic (and Accessories) · 243d
Cleared Dec 23, 2008
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
K081768 · Cook Incorporated
NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 186d
Cleared Dec 23, 2008
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K082677 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 99d
Cleared Dec 16, 2008
STRYKER VIDEOSCOPE
K082451 · Stryker Endoscopy
HET · Laparoscope, Gynecologic (and Accessories) · 113d
Cleared Nov 26, 2008
RAPIDVIT AND RAPIDWARM CLEAVE
K080446 · Vitrolife Sweden AB
MQL · Media, Reproductive · 281d
Cleared Nov 26, 2008
FETAL & MATERNAL MONITOR, MODEL F6, F9
K082602 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 79d

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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 OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 24 HIL Tampon, Menstrual, Scented, Scented-deodorized 24