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

976–1000 of 1727

Cleared Feb 18, 1999

P-1 (PREIMPLANTATION STAGE ONE) MEDIUM

K983589 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 128d

Cleared Feb 08, 1999

HUMAN SERUM ALBUMIN (HSA)

K983584 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 118d

Cleared Feb 08, 1999

TRANSMYOMETRIAL EMBRYO TRANSFER SET

K983595 · Cook Ob/Gyn

MQF · Catheter, Assisted Reproduction · 118d

Cleared Feb 05, 1999

OMNIFLATOR 7640 MODEL 7-640-00

K983326 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 136d

Cleared Feb 05, 1999

INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING

K983596 · Cook Ob/Gyn

MQH · Microtools, Assisted Reproduction (pipettes) · 115d

Cleared Feb 03, 1999

ENDOPATH ULTRA VERESS NEEDLE

K983925 · Ethicon Endo-Surgery, Inc.

HIF · Insufflator, Laparoscopic · 90d

Cleared Feb 01, 1999

COOK MINI-INCUBATOR

K983642 · Cook Ob/Gyn

MQG · Accessory, Assisted Reproduction · 108d

Cleared Feb 01, 1999

K983901 · KARL STORZ Endoscopy-America, Inc.

HIH · Hysteroscope (and Accessories) · 90d

Cleared Jan 21, 1999

OVUM PICK-UP ASPIRATION NEEDLES

K983593 · Cook Ob/Gyn

MQE · Needle, Assisted Reproduction · 100d

Cleared Jan 08, 1999

KSEA MONOPOLAR VAPORIZATION ELECTRODES

K983569 · KARL STORZ Endoscopy-America, Inc.

HIH · Hysteroscope (and Accessories) · 87d

Cleared Dec 21, 1998

GIFT CATHETER SET/S

K983590 · Cook Ob/Gyn

MQF · Catheter, Assisted Reproduction · 69d

Cleared Dec 21, 1998

INTRATUBAL TRANSFER SETS

K983591 · Cook Ob/Gyn

MQF · Catheter, Assisted Reproduction · 69d

Cleared Dec 21, 1998

EMBRYO TRANSFER CATHETERS/SETS

K983594 · Cook Ob/Gyn

MQF · Catheter, Assisted Reproduction · 69d

Cleared Dec 16, 1998

HYSTEROSCOPIC GIFT CATHETER SETS

K983587 · Cook Ob/Gyn

MQF · Catheter, Assisted Reproduction · 64d

Cleared Dec 16, 1998

COOK TEST TUBE HEATER

K983609 · Cook Ob/Gyn

MQG · Accessory, Assisted Reproduction · 63d

Cleared Sep 30, 1998

CO2 GAS WARMING UNIT (6-800-00)

K972675 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 441d

Cleared Sep 30, 1998

OMNIFLATOR 6630(6-630-00)

K973447 · Northgate Technologies, Inc.

HIF · Insufflator, Laparoscopic · 384d

Cleared Sep 10, 1998

LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)

K981334 · Richard Wolf Medical Instruments Corp.

HIF · Insufflator, Laparoscopic · 150d

Cleared Sep 10, 1998

SMITH & NEPHEW DYONICS MICROLAPAROSCOPE

K982149 · Smith & Nephew, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 84d

Cleared Aug 21, 1998

AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP

K980976 · Hollister, Inc.

HDB · Extractor, Vacuum, Fetal · 158d

Cleared Aug 19, 1998

KSEA ENDO TIP SYSTEM

K981130 · KARL STORZ Endoscopy-America, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 142d

Cleared Jul 20, 1998

WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES

K980302 · Richard Wolf Medical Instruments Corp.

HIH · Hysteroscope (and Accessories) · 174d

Cleared Jul 14, 1998

SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)

K974730 · Graphic Controls Corp.

KXO · Monitor, Pressure, Intrauterine · 208d

Cleared Jul 10, 1998

DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA

K974763 · Deroyal Industries, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 203d

Cleared May 08, 1998

KSEA PLASTIC TROCARS

K980694 · KARL STORZ Endoscopy-America, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 74d

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