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

3167 Obstetrics & Gynecology devices

2476–2500 of 3167

Cleared Dec 15, 1992

K921884 · Valleylab, Inc.

HGI · Electrocautery, Gynecologic (and Accessories) · 238d

Cleared Oct 09, 1992

K921264 · W.O.M. World of Medicine GmbH

HIF · Insufflator, Laparoscopic · 207d

Cleared Sep 29, 1992

AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE

K915331 · United States Surgical, A Division of Tyco Healthc

HET · Laparoscope, Gynecologic (and Accessories) · 308d

Cleared Sep 28, 1992

CONDUCTIVE SURGIGRIP SPIRAL SLEEVE

K915338 · United States Surgical, A Division of Tyco Healthc

HET · Laparoscope, Gynecologic (and Accessories) · 307d

Cleared Sep 23, 1992

K921222 · Valleylab, Inc.

HGI · Electrocautery, Gynecologic (and Accessories) · 194d

Cleared Sep 15, 1992

ULTRACELL INSTRUMENT WIPE

K920353 · Ultracell Medical Technologies, Inc.

HEP · Monitor, Blood-flow, Ultrasonic · 232d

Cleared Sep 04, 1992

NEW FREEDOM ULTRA THIN PADS

K920830 · Kimberly-Clark Corp.

HHD · Pad, Menstrual, Unscented · 193d

Cleared Sep 02, 1992

JANSEN-ANDERSON INSEMINATION SET

K914150 · Cook Ob/Gyn

MFD · Cannula, Intrauterine Insemination · 352d

Cleared Jun 29, 1992

K915378 · Edward Weck, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 213d

Cleared Jun 18, 1992

MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR

K915694 · Medical Devices, Inc.

HIF · Insufflator, Laparoscopic · 178d

Cleared Jun 12, 1992

TROCAR SHEATH ANCHOR

K915116 · Origin Medsystems, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 212d

Cleared Jun 04, 1992

MODIFICATION MODEL 7201 INSUFFLATOR

K915051 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 251d

Cleared May 18, 1992

LAPAROCOPIC MYOMA SCREW

K915388 · Cook Urological, Inc.

HHO · Screw, Fibroid, Gynecological · 171d

Cleared May 18, 1992

HYSTEROSCOPIC MYOMA SCREW

K915412 · Cook Urological, Inc.

HHO · Screw, Fibroid, Gynecological · 168d

Cleared Apr 27, 1992

COROMETRICS MODEL 150 FETAL MONITOR

K920376 · Ge Medical Systems Information Technologies

HGM · System, Monitoring, Perinatal · 89d

Cleared Apr 20, 1992

THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES

K914309 · Hill-Rom, Inc.

HDD · Table, Obstetrical, Ac-powered (and Accessories) · 208d

Cleared Apr 07, 1992

K912075 · Medical Device Inspection Co., Inc.

KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 333d

Cleared Apr 02, 1992

OTT INSUFFLATOR FILTER PLUS/TUBING SET

K914153 · Marlo Surgical Technology

HIF · Insufflator, Laparoscopic · 199d

Cleared Mar 27, 1992

SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR

K913848 · Sharplan Lasers, Inc.

MGI · Aspirator, Ultrasonic · 213d

Cleared Mar 20, 1992

SYSTEM 3000 ELECTRONIC INSUFFLATOR

K913873 · Cabot Medical Corp.

HIF · Insufflator, Laparoscopic · 204d

Cleared Mar 19, 1992

RG27-SERIES RESECTOSCOPE AND ACCESSORIES

K914108 · CooperSurgical, Inc.

HIH · Hysteroscope (and Accessories) · 188d

Cleared Feb 28, 1992

DAVOL ELECTROSUGICAL PROBES

K915406 · Davol, Inc.

HFG · Coagulator, Laparoscopic, Unipolar (and Accessories) · 88d

Cleared Feb 14, 1992

SOF-FLEX LAPAROSCOPIC BASKET

K913299 · Cook Ob/Gyn

HET · Laparoscope, Gynecologic (and Accessories) · 204d

Cleared Feb 13, 1992

SINGLE USE LEE ELECTRODE

K913213 · Aspen Laboratories, Inc.

HGI · Electrocautery, Gynecologic (and Accessories) · 209d

Cleared Feb 03, 1992

TROJAN (TM-TBD) CONDOM

K912901 · Carter Products

HIS · Condom · 216d

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