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

1727 Obstetrics & Gynecology devices

1251–1275 of 1727

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 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

DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR

K914968 · Ethicon, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 90d

Cleared Jan 14, 1992

MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER

K910742 · Graphic Controls Corp.

KXO · Monitor, Pressure, Intrauterine · 327d

Cleared Jan 09, 1992

MODEL SONICAID AXIS

K912890 · Oxford Medilog, Inc.

HGM · System, Monitoring, Perinatal · 192d

Cleared Dec 31, 1991

K912639 · Oxford Medilog, Inc.

HGM · System, Monitoring, Perinatal · 200d

Cleared Dec 18, 1991

THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR

K912498 · KARL STORZ Endoscopy-America, Inc.

HIG · Insufflator, Hysteroscopic · 196d

Cleared Dec 17, 1991

ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF

K912398 · Ethicon, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 207d

Cleared Nov 27, 1991

UNIVERSAL GENERAL USE KIT #7-510-16

K914401 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 56d

Cleared Nov 27, 1991

RECIRCULATION KIT #7-510-18

K914402 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 56d

Cleared Nov 27, 1991

GENERAL USE KIT #7-510-20

K914403 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 56d

Cleared Nov 13, 1991

VERRES NEEDLES 5 & 6 INCHES

K911179 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 240d

Cleared Nov 05, 1991

STAYFREE(TM) MAXI-PAD

K913747 · Personal Products Co.

HHD · Pad, Menstrual, Unscented · 76d

Cleared Sep 24, 1991

UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR

K912552 · Personal Products Co.

HEB · Tampon, Menstrual, Unscented · 105d

Cleared Sep 18, 1991

K905263 · Utah Medical Products, Inc.

HGI · Electrocautery, Gynecologic (and Accessories) · 299d

Cleared Aug 26, 1991

AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV

K910921 · United States Surgical, A Division of Tyco Healthc

HET · Laparoscope, Gynecologic (and Accessories) · 174d

Cleared Jul 26, 1991

MAJOLI UTERINE MANIPULATOR/INJECTOR

K911887 · Cook Ob/Gyn

LKF · Cannula, Manipulator/injector, Uterine · 88d

Cleared Jul 16, 1991

LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100

K910418 · Graphic Controls Corp.

HGM · System, Monitoring, Perinatal · 167d

Cleared Jul 03, 1991

LAPAROSCOPIC FORCEPS

K911474 · United States Endoscopy Group, Inc.

HCZ · Forceps, Surgical, Gynecological · 90d

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