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

3156 Obstetrics & Gynecology devices

1526–1550 of 3156

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 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 Jun 27, 2003

BLASTFREEZE AND BLASTTHAW

K031486 · Medicult A/S

MQL · Media, Reproductive · 46d

Cleared Jun 24, 2003

SYNVITRO HYADASE

K031228 · Medicult A/S

MQL · Media, Reproductive · 67d

Cleared Jun 23, 2003

BERKELEY V-10 VACUUM CURETTAGE SYSTEM

K030935 · Acmi Corporation

HHI · System, Abortion, Vacuum · 90d

Cleared Jun 23, 2003

K031015 · Vitrolife Sweden AB

MQL · Media, Reproductive · 84d

Cleared Jun 06, 2003

MEDELA PUMP IN STYLE ADVANCED BREAST PUMP

K031614 · Medela, Inc.

HGX · Pump, Breast, Powered · 14d

Cleared Apr 30, 2003

AQUASENS FLUID MONITORING SYSTEM

K031213 · Davol, Inc.

HIG · Insufflator, Hysteroscopic · 13d

Cleared Apr 10, 2003

COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS

K021237 · CooperSurgical, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 357d

Cleared Feb 24, 2003

PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A

K023931 · Philips Medical Systems, Inc.

HGM · System, Monitoring, Perinatal · 90d

Not Cleared Jan 31, 2003

BREASTVIEW VISUAL MAPPING SYSTEM

DEN020001 · Assurance Medical

NKA · System, Documentation, Breast Lesion · 248d

Cleared Jan 24, 2003

40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0

K022052 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 214d

Cleared Jan 24, 2003

VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V

K022445 · Olympus Optical Co., Ltd.

HIH · Hysteroscope (and Accessories) · 183d

Cleared Jan 22, 2003

SYDNEY IVF EMBRYO BIOPSY MEDIUM

K023850 · Cook Ob/Gyn

MQL · Media, Reproductive · 64d

Cleared Jan 22, 2003

COOPERSURGICAL OOCYTE RECOVERY NEEDLES

K023930 · CooperSurgical, Inc.

MQE · Needle, Assisted Reproduction · 58d

Cleared Dec 20, 2002

SYDNEY IVF HYALURONIDASE

K023353 · Cook Urological, Inc.

MQL · Media, Reproductive · 74d

Cleared Dec 16, 2002

TROJAN MINT TINGLE BRAND LATEX CONDOMS

K023405 · Armkel, LLC

HIS · Condom · 67d

Cleared Dec 13, 2002

SPERMGRAD, MODELS 10022/10063

K023403 · Vitrolife Sweden AB

MQL · Media, Reproductive · 64d

Cleared Dec 12, 2002

INTRAUTERINE DELIVERY SYSTEM - INJECTOR

K023051 · Prosurg, Inc.

LKF · Cannula, Manipulator/injector, Uterine · 90d

Cleared Nov 26, 2002

ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)

K023033 · Intl., Inc.

MQL · Media, Reproductive · 75d

Cleared Nov 04, 2002

HYALURONIDASE SOLUTION

K022931 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 61d

Cleared Nov 01, 2002

PLAYTEX BREAST PUMP

K022594 · Playtex Products, Inc.

HGX · Pump, Breast, Powered · 88d

Cleared Sep 16, 2002

MODIFICATION TO PLAYTEX TAMPONS #24002

K022882 · Playtex Products, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 17d

Cleared Sep 12, 2002

G-RINSE, MODEL 10031

K022295 · Vitrolife Sweden AB

MQL · Media, Reproductive · 58d

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