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

1201–1225 of 1727

Cleared Mar 22, 1994

INSUFFLATION TUBING

K924481 · Applied Medical Resources

HIF · Insufflator, Laparoscopic · 565d

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

DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING

K934131 · Deroyal Industries, Inc.

HIF · Insufflator, Laparoscopic · 194d

Cleared Mar 07, 1994

DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET

K935503 · Davol, Inc.

HIF · Insufflator, Laparoscopic · 111d

Cleared Mar 04, 1994

K925558 · Medsurg Industries, Inc.

HIF · Insufflator, Laparoscopic · 486d

Cleared Mar 02, 1994

KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+

K930149 · Kimberly-Clark Corp.

HEB · Tampon, Menstrual, Unscented · 414d

Cleared Feb 28, 1994

CRYOMEDICS LLETZ LOOPS

K923570 · Cabot Medical Corp.

HGI · Electrocautery, Gynecologic (and Accessories) · 591d

Cleared Feb 25, 1994

DETECT (TM) CYTOLOGY BRUSH

K933415 · Cook Ob/Gyn

HHT · Spatula, Cervical, Cytological · 227d

Cleared Feb 17, 1994

RESECTOSCOPE SHEATH

K931994 · Olympus Corp.

HIH · Hysteroscope (and Accessories) · 300d

Cleared Feb 16, 1994

16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)

K931338 · Aaron Medical Industries

HGI · Electrocautery, Gynecologic (and Accessories) · 337d

Cleared Feb 14, 1994

AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER

K934525 · United States Surgical, A Division of Tyco Healthc

HFW · Clamp, Umbilical · 150d

Cleared Dec 23, 1993

TROCAR STABILITY THREAD

K923568 · Applied Medical Resources

HET · Laparoscope, Gynecologic (and Accessories) · 524d

Cleared Dec 10, 1993

MOTHERS TOUCH ONE HAND BREAST PUMP

K912355 · Hollister, Inc.

HGY · Pump, Breast, Non-powered · 927d

Cleared Nov 05, 1993

TROCAR W/ BLUNT TIP OBTURATOR

K923636 · Applied Medical Resources

HET · Laparoscope, Gynecologic (and Accessories) · 472d

Cleared Oct 15, 1993

MEDSURG CIRCUMCISION TRAY

K920838 · Medsurg Industries, Inc.

HFK · Mold, Vaginal · 599d

Cleared Oct 08, 1993

URESIL LAPAROSCOPIC RETRACTOR

K921417 · Uresil Corp.

HET · Laparoscope, Gynecologic (and Accessories) · 563d

Cleared Sep 24, 1993

HEWLETT PACKARD MODEL M1353A FETAL MONITOR

K921956 · Hewlett-Packard Co.

HGM · System, Monitoring, Perinatal · 515d

Cleared Sep 24, 1993

HEWLETT-PACKARD MODEL M1351A FETAL MONITOR

K921957 · Hewlett-Packard Co.

HGM · System, Monitoring, Perinatal · 515d

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