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

3157 Obstetrics & Gynecology devices

1751–1775 of 3157

Cleared Dec 06, 1999

QUANTITATIVE SENTINEL SYSTEM

K993008 · Marquette Medical Systems, Inc.

HGM · System, Monitoring, Perinatal · 90d

Cleared Dec 03, 1999

GYRUS HYSTEROSCOPIC RESECTOSCOPE

K993749 · Gyrus Medical , Ltd.

HIH · Hysteroscope (and Accessories) · 28d

Cleared Nov 23, 1999

LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT

K991906 · Richard Wolf Medical Instruments Corp.

HIF · Insufflator, Laparoscopic · 186d

Cleared Oct 29, 1999

DR. JAHANGER'S CUTTER

K990738 · M.S. Jahanger, MD

KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 238d

Cleared Oct 27, 1999

COOK ULTRA QUIET VACUUM PUMP & REGULATOR

K992070 · Cook Urological, Inc.

MQG · Accessory, Assisted Reproduction · 131d

Cleared Oct 26, 1999

TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM

K992544 · Circon Corp.

HEX · Colposcope (and Colpomicroscope) · 88d

Cleared Oct 26, 1999

GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)

K992926 · Ri Mos. S.R.L.

HHK · Curette, Suction, Endometrial (and Accessories) · 56d

Cleared Oct 14, 1999

MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY

K990372 · Dr. Fritz GmbH

HET · Laparoscope, Gynecologic (and Accessories) · 248d

Cleared Oct 13, 1999

CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C

K991563 · Henke Sass Wolf of America, Inc.

HIH · Hysteroscope (and Accessories) · 161d

Cleared Sep 29, 1999

WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM

K992736 · Wallach Surgical Devices, Inc.

HIB · Speculum, Vaginal, Nonmetal · 47d

Cleared Sep 24, 1999

DISPOSABLE HEATING TUBING SET #7642HSES

K990662 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

HIF · Insufflator, Laparoscopic · 207d

Cleared Sep 24, 1999

PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED

K991378 · Sage Biopharma

MQL · Media, Reproductive · 156d

Cleared Sep 24, 1999

PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA

K991381 · Pacific Andrology, Inc.

MQL · Media, Reproductive · 156d

Cleared Sep 23, 1999

MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES

K992480 · Medifix, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 59d

Cleared Sep 17, 1999

CO2 GAS WARMER II, MODEL 6-800-00

K992381 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 63d

Cleared Sep 14, 1999

MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI

K991419 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 144d

Cleared Sep 13, 1999

ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M

K991388 · Pacific Andrology, Inc.

MQH · Microtools, Assisted Reproduction (pipettes) · 145d

Cleared Sep 13, 1999

DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO

K991799 · Davol Inc., Sub. C. R. Bard, Inc.

HIG · Insufflator, Hysteroscopic · 110d

Cleared Sep 13, 1999

EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER

K992307 · Fertility Technology Resources, Inc.

MQF · Catheter, Assisted Reproduction · 66d

Cleared Sep 13, 1999

OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138

K992308 · Lifetek Medical, Inc.

MQE · Needle, Assisted Reproduction · 66d

Cleared Sep 09, 1999

DOUBLE LUMEN NEEDLE

K991020 · Intl., Inc.

MQE · Needle, Assisted Reproduction · 164d

Cleared Sep 09, 1999

SPERM WASHING MEDIA

K991022 · Intl., Inc.

MQL · Media, Reproductive · 164d

Cleared Sep 09, 1999

SINGLE LUMEN NEEDLE

K991262 · Intl., Inc.

MQE · Needle, Assisted Reproduction · 149d

Cleared Sep 09, 1999

SINGLE LUMEN SIDEPORT NEEDLE

K991264 · Intl., Inc.

MQE · Needle, Assisted Reproduction · 149d

Cleared Sep 09, 1999

EMBRYO TRANSFER CATHETER CC GLIDER

K991266 · Intl., Inc.

MQF · Catheter, Assisted Reproduction · 149d

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