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

951–975 of 1727

Cleared Dec 06, 1999

TYRODE'S SOLUTION-ACIDIFIED

K991339 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 231d

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 27, 1999

COOK ULTRA QUIET VACUUM PUMP & REGULATOR

K992070 · Cook Urological, Inc.

MQG · Accessory, Assisted Reproduction · 131d

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 09, 1999

KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR

K992027 · Karl Storz Endoscopy

HIH · Hysteroscope (and Accessories) · 85d

Cleared Aug 31, 1999

K990536 · Personal Products Co.

HEB · Tampon, Menstrual, Unscented · 193d

Cleared Jul 26, 1999

WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N

K990348 · CooperSurgical, Inc.

MQF · Catheter, Assisted Reproduction · 171d

Cleared Jul 26, 1999

WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST

K990349 · CooperSurgical, Inc.

MQF · Catheter, Assisted Reproduction · 171d

Cleared Jul 26, 1999

WALLACE CATHETERS-18CM, MODEL 1816

K990350 · CooperSurgical, Inc.

MQF · Catheter, Assisted Reproduction · 171d

Cleared Jul 14, 1999

BOVINE SERUM ALBUMIN (BSA)

K991338 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 86d

Cleared Jul 14, 1999

PVP (POLYVINYLPYRROLIDONE)

K991343 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 86d

Cleared Jul 08, 1999

SPERM MAINTENANCE MEDIUM WITH GLYCEROL

K991337 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 80d

Cleared Jul 08, 1999

ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION

K991341 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 80d

Cleared Jul 08, 1999

PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION

K991342 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 80d

Cleared Jul 02, 1999

MODIFIED HAM'S F-10 WITH ALBUMIN

K991420 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 70d

Cleared Jul 02, 1999

FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)

K991421 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 70d

Cleared Jun 29, 1999

O.B. APPLICATOR TAMPONS, O.B. TAMPONS

K991118 · Personal Products Co.

HEB · Tampon, Menstrual, Unscented · 89d

Cleared May 11, 1999

MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE

K990411 · Karl Storz Endoscopy

HIH · Hysteroscope (and Accessories) · 90d

Cleared Apr 26, 1999

SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM

K983588 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 195d

Cleared Apr 23, 1999

SYNTHETIC SERUM SUBSTITUTE (SSS)

K983579 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 192d

Cleared Apr 16, 1999

BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771

K990147 · Richard Wolf Medical Instruments Corp.

HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 87d

Cleared Apr 02, 1999

K990004 · KARL STORZ Endoscopy-America, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 88d

Cleared Feb 18, 1999

BLASTOCYST MEDIUM

K983580 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 128d

Cleared Feb 18, 1999

HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI

K983586 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 128d

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