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
3179 Obstetrics & Gynecology devices
3151–3175 of 3179
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 Aug 03, 1977
FETAL MONITORING SYS. MODEL FM3R
K771379 · Sonicaid, Inc.
HGM · System, Monitoring, Perinatal · 8d
Cleared Jul 27, 1977
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K771149 · C.R. Bard, Inc.
HHK · Curette, Suction, Endometrial (and Accessories) · 30d
Cleared Jul 27, 1977
GUSBERG HYSTERECTOMY CLAMP
K771344 · J. Sklar Mfg. Co., Inc.
HGC · Clamp, Uterine · 14d
Cleared Jul 14, 1977
VAGINAL ILLUMINATOR, MODEL 78570
K771181 · Welch Allyn, Inc.
HDG · Speculum, Vaginal, Metal, Fiberoptic · 14d
Cleared Jul 14, 1977
DOPPLER (UTD-5 & UTD-6)
K771211 · Terumo America, Inc.
HEK · Monitor, Heart Sound, Fetal, Ultrasonic · 9d
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 Jan 12, 1977
LEFF STETHOSCOPE FOR FETAL HEART
K761338 · J. Sklar Mfg. Co., Inc.
HGN · Stethoscope, Fetal · 16d
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
AMMOCENTESIS TRAY (KIT)
K761230 · Pharmaseal Div., Baxter Healthcare Corp.
HIO · Sampler, Amniotic Fluid (amniocentesis Tray) · 7d
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
Cleared Dec 16, 1976
T-M (TIME-MOTION) OPTION
K761139 · G.D. Searle and Co.
HGM · System, Monitoring, Perinatal · 20d
Cleared Dec 13, 1976
EKOSECTOR I
K761030 · Smithkline Diagnostics, Inc.
HGM · System, Monitoring, Perinatal · 31d
Cleared Nov 11, 1976
STAYFREE DEODORANT MINI-PADS
K760853 · Personal Products Co.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 27d

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All categories 3179 NUC Lubricant, Personal 230 HET Laparoscope, Gynecologic (and Accessories) 225 MQL Media, Reproductive 218 HGX Pump, Breast, Powered 209 HIS Condom 200 HEB Tampon, Menstrual, Unscented 157 HGM System, Monitoring, Perinatal 155 HIH Hysteroscope (and Accessories) 145 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 44 HIG Insufflator, Hysteroscopic 43