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

1151–1175 of 1727

Cleared Dec 21, 1994

UNSCENTED MENSTRUAL TAMPONS

K944834 · Tambrands, Inc.

HEB · Tampon, Menstrual, Unscented · 82d

Cleared Dec 15, 1994

HASSON OPEN LAPAROSCOPY CANNULA

K942447 · Linvatec Corp.

HET · Laparoscope, Gynecologic (and Accessories) · 206d

Cleared Dec 15, 1994

KARL STORZ INSULATED SCISSORS

K944297 · KARL STORZ Endoscopy-America, Inc.

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 100d

Cleared Dec 15, 1994

KARL STORZ INSULATED BIOPSY FORCEPS

K944300 · KARL STORZ Endoscopy-America, Inc.

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 100d

Cleared Dec 12, 1994

FINESSE IEC/601

K941251 · Utah Medical Products, Inc.

HGI · Electrocautery, Gynecologic (and Accessories) · 272d

Cleared Dec 05, 1994

R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050

K935301 · R & D Batteries, Inc.

HGM · System, Monitoring, Perinatal · 397d

Cleared Dec 05, 1994

R AND D BATTERIES

K935377 · R & D Batteries, Inc.

HGM · System, Monitoring, Perinatal · 392d

Cleared Nov 30, 1994

K931065 · Northgate Technologies, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 639d

Cleared Nov 17, 1994

INSUFFLATOR TUBING WITH FILTER

K943508 · Stryker Endoscopy

HET · Laparoscope, Gynecologic (and Accessories) · 120d

Cleared Nov 15, 1994

ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER

K943954 · Conmedcorp

HIF · Insufflator, Laparoscopic · 92d

Cleared Nov 03, 1994

COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES

K943776 · Richard Wolf Medical Instruments Corp.

HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 93d

Cleared Oct 20, 1994

LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE

K943732 · Graphic Controls Corp.

HGP · Electrode, Circular (spiral), Scalp And Applicator · 79d

Cleared Oct 17, 1994

K930912 · Northgate Technologies, Inc.

HIG · Insufflator, Hysteroscopic · 602d

Cleared Sep 28, 1994

ZEISS OPMI L STEREO-LAPAROSCOPE

K931478 · Carl Zeiss, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 553d

Cleared Sep 27, 1994

TUBAL LUMEN SUPPORT

K932114 · Cook Ob/Gyn

HFJ · Prosthesis, Fallopian Tube · 512d

Cleared Aug 30, 1994

ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES

K925560 · Zinnanti Surgical Instruments, Inc.

HGI · Electrocautery, Gynecologic (and Accessories) · 665d

Cleared Aug 19, 1994

NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600

K935862 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 259d

Cleared Aug 15, 1994

MODEL 118 FETAL/MATERNAL MONITOR

K934959 · Ge Medical Systems Information Technologies

HGM · System, Monitoring, Perinatal · 304d

Cleared Aug 15, 1994

MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM

K942887 · Hewlett-Packard Co.

HGM · System, Monitoring, Perinatal · 56d

Cleared Aug 02, 1994

K941272 · Welch Allyn, Inc.

HIB · Speculum, Vaginal, Nonmetal · 139d

Cleared Jul 25, 1994

AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR

K930867 · United States Surgical, A Division of Tyco Healthc

LKF · Cannula, Manipulator/injector, Uterine · 521d

Cleared Jun 30, 1994

THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV

K930954 · Cabot Medical Corp.

HIB · Speculum, Vaginal, Nonmetal · 492d

Cleared Jun 27, 1994

ELECTROSURGICAL ELECTRODE

K925478 · Megadyne Medical Products, Inc.

HGI · Electrocautery, Gynecologic (and Accessories) · 606d

Cleared Jun 27, 1994

K941863 · Personal Products Co.

HEB · Tampon, Menstrual, Unscented · 73d

Cleared Jun 24, 1994

STOVALL ENDOMETRIAL BRUSH

K911620 · Cook Ob/Gyn

HFE · Brush, Endometrial · 1170d

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