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
1732 Obstetrics & Gynecology devices
1551–1575 of 1732
Cleared Aug 12, 1986
SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON
K861911 · Tambrands, Inc.
HEB · Tampon, Menstrual, Unscented · 85d
Cleared Aug 12, 1986
SUPER PLUS TAMPAX TAMPONS
K861912 · Tambrands, Inc.
HEB · Tampon, Menstrual, Unscented · 85d
Cleared Aug 12, 1986
SLENDER REGULAR TAMPAX TAMPONS
K861913 · Tambrands, Inc.
HEB · Tampon, Menstrual, Unscented · 85d
Cleared Aug 12, 1986
CABOT MEDICAL VARIABLE FLOW INSUFFLATOR
K862310 · Cabot Medical Corp.
HES · Insufflator, Carbon-dioxide, Uterotubal (and Accessories) · 56d
Cleared Aug 12, 1986
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
K862456 · Cooper Lasersonics, Inc.
HHR · Laser, Surgical, Gynecologic · 46d
Cleared Aug 11, 1986
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
K861845 · Directed Energy, Inc.
HHR · Laser, Surgical, Gynecologic · 90d
Cleared Jul 31, 1986
645OB SECTOR/LINEAR ULTRASOUND SCANNER
K861931 · Ge Medical Systems Information Technologies
HEM · Imager, Ultrasonic Obstetric-gynecologic · 72d
Cleared Jul 18, 1986
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
K861544 · Hewlett-Packard Co.
HGM · System, Monitoring, Perinatal · 85d
Cleared Jul 14, 1986
TRANSVAGINAL PROBE, MODEL ED65M-TV
K861371 · Elscint, Inc.
HGL · Transducer, Ultrasonic, Obstetric · 94d
Cleared Jul 09, 1986
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)
K862353 · Tambrands, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 19d
Cleared Jul 08, 1986
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K862285 · Kimberly-Clark Corp.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 22d
Cleared Jun 09, 1986
KOTEX PROFILE SHAPED MAXI PAD
K861902 · Kimberly-Clark Corp.
HHD · Pad, Menstrual, Unscented · 24d
Cleared Jun 02, 1986
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
K860233 · General Electric Co.
HEM · Imager, Ultrasonic Obstetric-gynecologic · 131d
Cleared May 23, 1986
TRANSVAGINAL TRANSDUCER, 5MHZ
K860234 · Philips Medical Systems, Inc.
HGL · Transducer, Ultrasonic, Obstetric · 121d
Cleared Apr 14, 1986
MX4040 INTRAUTERINE PRESSURE MONITORING KIT
K860101 · Medex, Inc.
KXO · Monitor, Pressure, Intrauterine · 94d
Cleared Apr 08, 1986
TECNOL SECURE-ALL FETAL MONITOR STRAP
K861189 · Tecnol New Jersey Wound Care, Inc.
HGM · System, Monitoring, Perinatal · 8d
Cleared Mar 17, 1986
HURWITZ AMNIOCENTESIS NEEDLE
K854725 · Bd Becton Dickinson Vacutainer Systems Preanalytic
HIO · Sampler, Amniotic Fluid (amniocentesis Tray) · 115d
Cleared Mar 17, 1986
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
K860313 · Johnson & Johnson Professionals, Inc.
HGL · Transducer, Ultrasonic, Obstetric · 48d
Cleared Mar 13, 1986
KOTEX OVERNITE
K860587 · Kimberly-Clark Corp.
HHD · Pad, Menstrual, Unscented · 22d
Cleared Feb 04, 1986
CO2 LASER LAPAROSCOPE SYSTEM
K854361 · Richard Wolf Medical Instruments Corp.
HHR · Laser, Surgical, Gynecologic · 98d
Cleared Jan 24, 1986
MEDSURG AMNIOCENTESIS TRAY
K854290 · Medsurg Industries, Inc.
· 91d
Cleared Dec 18, 1985
5.0 MHZ INTRACAVITARY SECTOR PROBE
K853711 · General Electric Co.
HEM · Imager, Ultrasonic Obstetric-gynecologic · 104d
Cleared Nov 07, 1985
BELIEVE HEAVY FLOW PROTECTION LABIAL PADS
K853630 · Kimberly-Clark Corp.
HHD · Pad, Menstrual, Unscented · 69d
Cleared Oct 29, 1985
WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL
K853640 · Downs Surgical , Ltd.
HDF · Speculum, Vaginal, Metal · 70d
Cleared Oct 23, 1985
OCS-2 COLPOSCOPE
K852980 · Olympus Corp.
HEX · Colposcope (and Colpomicroscope) · 100d

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All categories 1732 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 MQL Media, Reproductive 121 NUC Lubricant, Personal 121 HIH Hysteroscope (and Accessories) 107 HEB Tampon, Menstrual, Unscented 100 HGM System, Monitoring, Perinatal 86 HIF Insufflator, Laparoscopic 81 HHD Pad, Menstrual, Unscented 54 LKF Cannula, Manipulator/injector, Uterine 43 HHL Pad, Menstrual, Scented, Scented-deodorized 38 HIS Condom 37 HIG Insufflator, Hysteroscopic 28 OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 24 HIL Tampon, Menstrual, Scented, Scented-deodorized 24