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

3101–3125 of 3179

Cleared Jan 28, 1980

STERILIZATION PROCESS/DBL. GRIP CORD CLP

K792631 · Procter & Gamble Mfg. Co.

KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 40d

Cleared Dec 13, 1979

SANITARY/OB PAD

K792296 · American Hospital Supply Corp.

HHD · Pad, Menstrual, Unscented · 30d

Cleared Nov 16, 1979

DEODORANT CAREFREE PANTY SHIELDS

K792195 · Personal Products Co.

HHL · Pad, Menstrual, Scented, Scented-deodorized · 15d

Cleared Nov 05, 1979

MASTERSON* ENDOMETRIAL BIOPSY KIT

K791765 · Codman & Shurtleff, Inc.

HHK · Curette, Suction, Endometrial (and Accessories) · 69d

Cleared Sep 17, 1979

KOLPOSKOP KP20005

K791279 · Elmed, Inc.

HEX · Colposcope (and Colpomicroscope) · 69d

Cleared Sep 17, 1979

KOTEX LIGHTDAYS DEODORANT PATILINERS

K791433 · Kimberly-Clark Corp.

HHL · Pad, Menstrual, Scented, Scented-deodorized · 52d

Cleared Aug 22, 1979

MODEL 6500 EXTRACTION IRRIGATION SYS

K791277 · Cavitron Corp.

HDQ · Dilator, Cervical, Fixed Size · 43d

Cleared Aug 03, 1979

K791274 · Procter & Gamble Mfg. Co.

HEB · Tampon, Menstrual, Unscented · 25d

Cleared Jul 30, 1979

MONOJECT ENDOMETRIAL SAMPLING KIT

K790875 · Sherwood Medical Co.

HHK · Curette, Suction, Endometrial (and Accessories) · 84d

Cleared Mar 22, 1979

KOTEX TUBE AND STICK TAMPON

K790385 · Kimberly-Clark Corp.

HEB · Tampon, Menstrual, Unscented · 24d

Cleared Jan 17, 1979

LASER, CO2 SURGICAL

K782054 · Cavitron Corp.

HHR · Laser, Surgical, Gynecologic · 41d

Cleared Dec 07, 1978

UTERINE SOUND, BURNETT DISPOSABLE

K781766 · C.R. Bard, Inc.

HHM · Sound, Uterine · 52d

Cleared Dec 07, 1978

INSTRUMENT CURNETT MINI-CONER BIOPSY

K781767 · C.R. Bard, Inc.

KOH · Instrument, Manual, General Obstetric-gynecologic · 52d

Cleared Dec 04, 1978

INSUFFALATOR LAPARAOSCOPIC

HIF · Insufflator, Laparoscopic · 20d

Cleared Oct 17, 1978

UMBILICAL CORD CLAMP

K781548 · Hollister, Inc.

HFW · Clamp, Umbilical · 35d

Cleared Sep 26, 1978

MODEL 80032A, OBSTETRICAL TELEMETRY

K781359 · Hewlett-Packard Co.

HGM · System, Monitoring, Perinatal · 50d

Cleared Sep 14, 1978

FORCEPS, ELECTROSURGICAL

HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 76d

Cleared Sep 07, 1978

MODEL 80100A, PATIENT DATA MEMORY

K781360 · Hewlett-Packard Co.

HGM · System, Monitoring, Perinatal · 31d

Cleared Sep 07, 1978

MODESS* BELTLESS FEMININE NAPKIN

K781470 · Personal Products Co.

HHD · Pad, Menstrual, Unscented · 10d

Cleared Jul 17, 1978

ASSURE NATURAL FIT TAMPON

K781085 · Personal Products Co.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 18d

Cleared Jul 17, 1978

ONE INCISION BI-POLAR ELECTRO. FORCEPS

HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 18d

Cleared Jun 22, 1978

SCISSORS, HOOK, ELECTROSURGICAL

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 13d

Cleared Jun 22, 1978

SCISSORS, HOOK, ELECTROSURGICAL

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 13d

Cleared May 25, 1978

K780587 · Polamedco, Inc.

KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 44d

Cleared May 09, 1978

FETAL MONITORING SYSTEM

K780487 · Sonicaid, Inc.

HFO · Recorder, Pressure, Intrauterine · 43d

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