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
1701–1725 of 1732
Cleared Mar 02, 1978
DISPLAY SYSTEM MODEL 428
K780176 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 27d
Cleared Mar 02, 1978
FETAL MONITOR MODEL 112
K780177 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 27d
Cleared Mar 02, 1978
TAMPON, RELY MODIFIED
K780243 · Procter & Gamble Mfg. Co.
HEB · Tampon, Menstrual, Unscented · 17d
Cleared Jan 26, 1978
TAMPON, HEAVY DUTY, & STICK
K780058 · Kimberly-Clark Corp.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 14d
Cleared Nov 17, 1977
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
K772121 · Smithkline Diagnostics, Inc.
HHK · Curette, Suction, Endometrial (and Accessories) · 7d
Cleared Sep 20, 1977
PETITES BETWEEN-PERIOD PROTECTORS
K771547 · 3M Company
HHL · Pad, Menstrual, Scented, Scented-deodorized · 39d
Cleared Aug 25, 1977
SPIRAL SCALP ELECTRODE, 14499A
K771553 · Hewlett-Packard Co.
HGP · Electrode, Circular (spiral), Scalp And Applicator · 13d
Cleared Aug 04, 1977
ARTIUS SYSTEM
K771151 · General Electric Co.
HGL · Transducer, Ultrasonic, Obstetric · 41d
Cleared Aug 03, 1977
FETAL/MATERNAL ALRM MODULE - 21595A
K771194 · Hewlett-Packard Co.
HGM · System, Monitoring, Perinatal · 33d
Cleared Aug 03, 1977
FETAL/MATERNAL REPEATER - 21596A
K771195 · Hewlett-Packard Co.
HGM · System, Monitoring, Perinatal · 33d
Cleared Aug 03, 1977
MARKER GENERATOR MODULES - 21597A
K771196 · Hewlett-Packard Co.
HGM · System, Monitoring, Perinatal · 33d
Cleared Jul 27, 1977
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K771149 · C.R. Bard, Inc.
HHK · Curette, Suction, Endometrial (and Accessories) · 30d
Cleared Jul 14, 1977
VAGINAL ILLUMINATOR, MODEL 78570
K771181 · Welch Allyn, Inc.
HDG · Speculum, Vaginal, Metal, Fiberoptic · 14d
Cleared Jul 11, 1977
CIRCUMCISION KIT
K770873 · American Hospital Supply Corp.
FHG · Bell, Circumcision · 59d
Cleared Jun 24, 1977
ASSURE DEODORANT TAMPONS
K771012 · Personal Products Co.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 18d
Cleared May 20, 1977
COLPOSCOPE SYSTEM
K770697 · Richard Wolf Medical Instruments Corp.
HEX · Colposcope (and Colpomicroscope) · 35d
Cleared May 20, 1977
MAXI-PADS, STAYFREE
K770778 · Personal Products Co.
HHD · Pad, Menstrual, Unscented · 21d
Cleared Apr 26, 1977
CURETTE, UTERINE, VACUUM ASPIRATING
K770674 · American Hospital Supply Corp.
HHK · Curette, Suction, Endometrial (and Accessories) · 15d
Cleared Mar 09, 1977
LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS
K770378 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 12d
Cleared Mar 09, 1977
TROCAR SLEEVE SYSTEM
K770379 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 12d
Cleared Dec 17, 1976
CENTRAL STATION REPEATER (MODEL 8032A)
K760968 · Hewlett-Packard Co.
KXN · Monitor, Cardiac, Fetal · 43d
Cleared Dec 17, 1976
RELY TAMPON
K761184 · Procter & Gamble Mfg. Co.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 14d
Cleared Dec 17, 1976
STAYFREE MAXI PADS
K761233 · Personal Products Co.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 7d
Cleared Dec 16, 1976
V.I. OCTOSON ULTRASONIC SYSTEM
K760874 · General Electric Co.
HEM · Imager, Ultrasonic Obstetric-gynecologic · 59d
Cleared Dec 16, 1976
REAL TIME OBSTETRICAL ULTRASONIC SCANNER
K761052 · Smithkline Diagnostics, Inc.
HEM · Imager, Ultrasonic Obstetric-gynecologic · 31d

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All categories 1732 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 NUC Lubricant, Personal 121 MQL Media, Reproductive 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 HIL Tampon, Menstrual, Scented, Scented-deodorized 24 MQF Catheter, Assisted Reproduction 24