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
3153 Obstetrics & Gynecology devices
1251–1275 of 3153
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 18, 2008
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
K080172 · Medicult A/S
MQL · Media, Reproductive · 329d
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
Cleared Nov 26, 2008
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
K082730 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 69d
Cleared Nov 07, 2008
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066 · Cook Urological, Inc.
HFE · Brush, Endometrial · 108d
Cleared Nov 07, 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 81d
Cleared Oct 10, 2008
VITRIFICATION KIT & VITRIFICATION WARMING KIT
K073522 · Sage In-Vitro Fertilization, Inc.
MQL · Media, Reproductive · 301d
Cleared Sep 30, 2008
AVAULTA SUPPORT SYSTEM
K082571 · C.R. Bard, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 25d
Cleared Sep 26, 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K080948 · Olympus Medical Systems Corporation
HET · Laparoscope, Gynecologic (and Accessories) · 176d
Cleared Sep 19, 2008
ICSI CUMULASE
K081639 · Medicult A/S
MQL · Media, Reproductive · 100d
Cleared Sep 17, 2008
G-MOPS G5 SERIES
K081115 · Vitrolife Sweden AB
MQL · Media, Reproductive · 152d
Cleared Sep 16, 2008
G-1 V5
K081114 · Vitrolife Sweden AB
MQL · Media, Reproductive · 151d
Cleared Sep 16, 2008
G-2 V5
K081117 · Vitrolife Sweden AB
MQL · Media, Reproductive · 151d
Cleared Sep 03, 2008
EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
K080473 · Medicult A/S
MQL · Media, Reproductive · 195d
Cleared Sep 02, 2008
G-IVF G5 SERIES
K081116 · Vitrolife Sweden AB
MQL · Media, Reproductive · 137d
Cleared Aug 25, 2008
ORTHO ALL-FLEX DIAPHRAGM
K080040 · Johnson & Johnson Produtos Profissionais Ltda.
HDW · Diaphragm, Contraceptive (and Accessories) · 231d
Cleared Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
K081048 · Boston Scientific Corp
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 130d
Cleared Aug 13, 2008
SUNIVF DISHES
K080395 · Intl., Inc.
MQK · Labware, Assisted Reproduction · 182d
Cleared Jul 16, 2008
PRE-VA VAGINAL LUBRICANT
K072741 · Ingfertility, LLC
PEB · Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible · 293d
Cleared Jun 27, 2008
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
K081555 · Procter & Gamble Co.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 24d
Cleared Jun 19, 2008
DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
K072169 · Ssl Americas, Inc.
MOL · Condom, Synthetic · 318d

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All categories 3153 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