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
3156 Obstetrics & Gynecology devices
1576–1600 of 3156
Cleared Apr 29, 2002
BUSSE UMBILICAL CORD CLAMP CUTTER
K021055 · Busse Hospital Disposables, Inc.
HFW · Clamp, Umbilical · 28d
Cleared Apr 24, 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
K020954 · Ackrad Laboratories
LKF · Cannula, Manipulator/injector, Uterine · 30d
Cleared Apr 17, 2002
TAMPONADE UTERINE BALLOON CATHETER SET
K013597 · Cook Ob/Gyn
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 168d
Cleared Apr 16, 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951 · Ackrad Laboratories
LKF · Cannula, Manipulator/injector, Uterine · 22d
Cleared Mar 13, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34802
K020200 · Playtex Products, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 50d
Cleared Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K020201 · Playtex Products, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 49d
Cleared Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34702
K020202 · Playtex Products, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 49d
Cleared Mar 07, 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · Medela, Inc.
HGX · Pump, Breast, Powered · 16d
Cleared Mar 05, 2002
TROJAN PASSION BERRY GEL
K013433 · Armkel, LLC
NUC · Lubricant, Personal · 140d
Cleared Feb 08, 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc.
MQG · Accessory, Assisted Reproduction · 51d
Cleared Feb 01, 2002
TROJAN CRYSTAL CLEAR LIQUID
K013614 · Armkel, LLC
NUC · Lubricant, Personal · 88d
Cleared Jan 18, 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
K013518 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 87d
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 57d
Cleared Nov 28, 2001
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
K012917 · Dynarex Corp.
HFW · Clamp, Umbilical · 90d
Cleared Nov 19, 2001
SF SH CATHETER, MODEL R65-945
K013437 · A & A Medical, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 33d
Cleared Nov 19, 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491 · A & A Medical, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 28d
Cleared Nov 13, 2001
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 90d
Cleared Oct 24, 2001
EZ-ON CONDOM
K001974 · Mayer Laboratories
MOL · Condom, Synthetic · 482d
Cleared Oct 23, 2001
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 288d
Cleared Oct 05, 2001
ALWAYS DUETS
K012629 · Procter & Gamble Co.
HHD · Pad, Menstrual, Unscented · 53d
Cleared Sep 19, 2001
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
K011996 · Procter & Gamble Co.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 84d
Cleared Aug 27, 2001
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
K002328 · Richard Wolf Medical Instruments Corp.
HIF · Insufflator, Laparoscopic · 391d
Cleared Aug 16, 2001
AQUASENS FLUID MONITORING SYSTEM
K011069 · Davol Inc., Sub. C. R. Bard, Inc.
HIG · Insufflator, Hysteroscopic · 129d
Cleared Aug 15, 2001
AMEDA HYGIENIKIT
K011519 · Hollister, Inc.
HGY · Pump, Breast, Non-powered · 90d
Cleared Jul 18, 2001
OIL FOR EMBRYO CULTURE
K011938 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 27d

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Filter by Product Code

All categories 3156 NUC Lubricant, Personal 228 HET Laparoscope, Gynecologic (and Accessories) 225 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 206 HIS Condom 196 HGM System, Monitoring, Perinatal 155 HEB Tampon, Menstrual, Unscented 155 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