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

3165 Obstetrics & Gynecology devices

2376–2400 of 3165

Cleared Apr 19, 1994

C-SECTION, LABOR & DELIVERY TRAYS (PACKS)

K932216 · Associated Medical Products Co.

MLS · Labor And Delivery Kit · 347d

Cleared Apr 19, 1994

PLATEX TAMPONS MODEL NUMBER 07094

K941196 · Playtex Family Products, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 36d

Cleared Apr 11, 1994

LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS

K923259 · Imtec Corp.

HET · Laparoscope, Gynecologic (and Accessories) · 648d

Cleared Apr 07, 1994

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE

K926021 · Zinnanti Surgical Instruments, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 493d

Cleared Mar 31, 1994

MODEL 151 FETAL MONITOR

K932077 · Ge Medical Systems Information Technologies

HGM · System, Monitoring, Perinatal · 336d

Cleared Mar 30, 1994

ENDOMED LAPAROSCOPY INSTRUMENTS

K921686 · Buckman Co., Inc.

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 721d

Cleared Mar 30, 1994

LABOR AND DELIVERY TRAY

K936120 · Cush Medical Products

MLS · Labor And Delivery Kit · 97d

Cleared Mar 28, 1994

ELECTRONIC INSUFFLATOR MODEL 2054.61

K921756 · Richard Wolf Medical Instruments Corp.

HIF · Insufflator, Laparoscopic · 714d

Cleared Mar 25, 1994

DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP

K921405 · Davol, Inc.

HFG · Coagulator, Laparoscopic, Unipolar (and Accessories) · 731d

Cleared Mar 25, 1994

E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES

K921885 · Valleylab, Inc.

HGZ · Heater, Perineal, Direct Contact · 703d

Cleared Mar 25, 1994

PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED

K940821 · Playtex Family Products, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 31d

Cleared Mar 23, 1994

CARAPACE LABOR AND DELIVERY SETS

K931722 · Carapace, Inc.

MLS · Labor And Delivery Kit · 350d

Cleared Mar 22, 1994

INSUFFLATION TUBING

K924481 · Applied Medical Resources

HIF · Insufflator, Laparoscopic · 565d

Cleared Mar 17, 1994

ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET

K932118 · Core Dynamics, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 318d

Cleared Mar 17, 1994

TROGARD TROCAR SLEEVE RETAINING THREAD

K933130 · Conmedcorp

HET · Laparoscope, Gynecologic (and Accessories) · 262d

Cleared Mar 17, 1994

100 SERIES ENDOSCOPIC GRASPING FORCEPS

K933698 · Cook Urological, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 231d

Cleared Mar 17, 1994

HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS

K934451 · Cook Urological, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 185d

Cleared Mar 15, 1994

MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER

K931205 · Baxter Healthcare Corp

HHI · System, Abortion, Vacuum · 371d

Cleared Mar 11, 1994

FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE

K915857 · Olympus Corp.

HET · Laparoscope, Gynecologic (and Accessories) · 805d

Cleared Mar 11, 1994

ENDOPATH RELOADABLE LINEAR CUTTER

K930934 · Ethicon, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 381d

Cleared Mar 11, 1994

RETRACTORS AND SCRAPER

K933008 · Baxter Healthcare Corp

HET · Laparoscope, Gynecologic (and Accessories) · 263d

Cleared Mar 11, 1994

COOK LAPAROSCOPIC MINI RETRACTOR SET

K936026 · Cook Urological, Inc.

HFI · Coagulator, Culdoscopic (and Accessories) · 84d

Cleared Mar 07, 1994

CARAPACE PELVIC EXAM TRAYS

K931822 · Carapace, Inc.

MLT · Pelvic Exam Kit · 333d

Cleared Mar 07, 1994

PLAYTEX ULTIMATES TAMPONS

K932907 · Playtex Family Products, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 264d

Cleared Mar 07, 1994

PLAYTEX ULTIMATES TAMPONS

K932909 · Playtex Family Products, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 264d

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