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

4525

Total

4511

Cleared

167d

Avg (2y)

1976

Since

4525 Obstetrics & Gynecology devices

1701–1725 of 4525

Cleared Dec 09, 2003

MONA LISA ASPIRATION NEEDLE

K032208 · Fertility Technology Resources, Inc.

MQE · Needle, Assisted Reproduction · 144d

Cleared Dec 02, 2003

SMITH & NEPHEW IUR MORCELLATION SYSTEM

K031787 · Smith & Nephew, Inc.

HIH · Hysteroscope (and Accessories) · 175d

Cleared Nov 18, 2003

MARINA MEDICAL SILICONE PESSARY

K031463 · Marina Medical Instruments, Inc.

HHW · Pessary, Vaginal · 194d

Cleared Nov 14, 2003

KWIKEZE MALE CONDOM APPLICATOR

K031007 · Condax, LLC

HIS · Condom · 228d

Cleared Nov 14, 2003

PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)

K032636 · Playtex Products, Inc.

HEB · Tampon, Menstrual, Unscented · 79d

Cleared Oct 31, 2003

MERCATOR HEALTHCARE MALE LATEX CONDOM

K031369 · Mercator Healthcare , Ltd.

HIS · Condom · 184d

Cleared Oct 30, 2003

NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068

K033131 · The First Years, Inc.

HGX · Pump, Breast, Powered · 30d

Cleared Oct 08, 2003

MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM

K032772 · Hill-Rom Manufacturing, Inc.

HGM · System, Monitoring, Perinatal · 30d

Cleared Sep 29, 2003

ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0

K031974 · Asap Endoscopic Products GmbH

HIH · Hysteroscope (and Accessories) · 95d

Cleared Sep 23, 2003

CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER

K030966 · Boston Scientific Corp

NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 180d

Cleared Sep 17, 2003

FETAL SPIRAL ELECTRODE, MODEL FSE07000

K030691 · Clinical Innovations, Inc.

HGP · Electrode, Circular (spiral), Scalp And Applicator · 196d

Cleared Sep 15, 2003

NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP

K032566 · The First Years, Inc.

HGX · Pump, Breast, Powered · 25d

Cleared Sep 12, 2003

MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921

K030961 · Microlife Corp.

LHD · Device, Fertility Diagnostic, Proceptive · 169d

Cleared Sep 03, 2003

FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS

K032173 · First Quality Hygienic, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 49d

Cleared Aug 29, 2003

SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT

K030441 · Cook Ob/Gyn

MQL · Media, Reproductive · 199d

Cleared Aug 29, 2003

BINDER CO2 INCUBATOR SERIE CB

K032526 · Binder GmbH

MQG · Accessory, Assisted Reproduction · 14d

Cleared Aug 27, 2003

CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES

K030525 · Mid-Atlantic Diagnostics, Inc.

MQG · Accessory, Assisted Reproduction · 189d

Cleared Aug 27, 2003

KENTEX DISPOSABLE VAGINAL SPECULUM

K030693 · Kentron Health Care, Inc.

HIB · Speculum, Vaginal, Nonmetal · 175d

Cleared Aug 22, 2003

INTERMED ZOOM COLPOSCOPE

K031639 · Intermed Group, Inc.

HEX · Colposcope (and Colpomicroscope) · 87d

Cleared Aug 21, 2003

MODEL 120 SERIES MATERNAL/FETAL MONITOR

K032252 · Ge Medical Systems Information Technologies

HGM · System, Monitoring, Perinatal · 30d

Cleared Aug 20, 2003

ISM1+, IMS2+, AND UTM+

K030490 · Medicult A/S

MQL · Media, Reproductive · 187d

Cleared Aug 14, 2003

ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS

K032080 · Rostam , Ltd.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 38d

Cleared Aug 13, 2003

IUR FLUID MANAGEMENT SYSTEM

K031616 · W.O.M. World of Medicine AG

HIG · Insufflator, Hysteroscopic · 82d

Cleared Jul 14, 2003

FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS

K031067 · First Quality Hygienic, Inc.

HEB · Tampon, Menstrual, Unscented · 101d

Cleared Jun 27, 2003

HI-FLO THERME PNEU 45, WISAP #7083, 7083V

K031014 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

HIF · Insufflator, Laparoscopic · 88d

Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.

Search all Obstetrics & Gynecology 510(k) devices