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

1001–1025 of 1727

Cleared Apr 15, 1998

KSEA N2O ENDOFLATOR

K980134 · KARL STORZ Endoscopy-America, Inc.

HIF · Insufflator, Laparoscopic · 90d

Cleared Apr 10, 1998

VAPORIZATION ELECTRODES

K970961 · Richard Wolf Medical Instruments Corp.

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 389d

Cleared Apr 10, 1998

CO2 PNEUMO-DISSECTOR

K972647 · Cook Urological, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 269d

Cleared Feb 10, 1998

O.B. APPLICATOR AND NON-APPLICATOR TAMPONS

K974629 · Personal Products Co.

HEB · Tampon, Menstrual, Unscented · 60d

Cleared Feb 02, 1998

COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM

K972630 · CooperSurgical, Inc.

HEX · Colposcope (and Colpomicroscope) · 203d

Cleared Jan 22, 1998

KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES

K972488 · Karl Storz Endoscopy

HET · Laparoscope, Gynecologic (and Accessories) · 204d

Cleared Dec 19, 1997

KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES

K962985 · KARL STORZ Endoscopy-America, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 505d

Cleared Dec 16, 1997

BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM

K965008 · Spacelabs Medical, Inc.

HGM · System, Monitoring, Perinatal · 365d

Cleared Dec 12, 1997

MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M

K973737 · Richard Wolf Medical Instruments Corp.

HET · Laparoscope, Gynecologic (and Accessories) · 73d

Cleared Dec 12, 1997

CIRCUMCISION TRAY, CAT. NO. 70340

K974286 · Trinity Laboratories, Inc.

HFX · Clamp, Circumcision · 28d

Cleared Dec 02, 1997

MVM 3.3 MM MICROENDOSCOPE

K973304 · KARL STORZ Endoscopy-America, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 90d

Cleared Nov 25, 1997

ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR

K964276 · Richard Wolf Medical Instruments Corp.

HEW · Culdoscope (and Accessories) · 393d

Cleared Nov 12, 1997

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007

K973850 · Alexander Mfg. Co.

HFO · Recorder, Pressure, Intrauterine · 35d

Cleared Nov 07, 1997

VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR

K971836 · CooperSurgical, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 172d

Cleared Nov 05, 1997

MICRO ELECTRODES

K971838 · CooperSurgical, Inc.

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 170d

Cleared Oct 22, 1997

MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)

K971420 · Richard Wolf Medical Instruments Corp.

HIH · Hysteroscope (and Accessories) · 188d

Cleared Aug 08, 1997

ELECTROSURGICAL ELECRTRODES

K962271 · Northgate Technologies, Inc.

HIH · Hysteroscope (and Accessories) · 421d

Cleared Aug 06, 1997

AMR MINI-LAPAROSCOPE

K962777 · Applied Medical Resources

HET · Laparoscope, Gynecologic (and Accessories) · 385d

Cleared Aug 06, 1997

VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820

K971837 · CooperSurgical, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 79d

Cleared Jul 24, 1997

KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES

K971518 · KARL STORZ Endoscopy-America, Inc.

HIH · Hysteroscope (and Accessories) · 90d

Cleared Jul 03, 1997

K965245 · Utah Medical Products, Inc.

HGI · Electrocautery, Gynecologic (and Accessories) · 184d

Cleared Jul 03, 1997

K971809 · Irvine Scientific Sales Co., Inc.

MQL · Media, Reproductive · 49d

Cleared Jun 27, 1997

SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS

K971188 · Smith & Nephew, Inc.

HIH · Hysteroscope (and Accessories) · 88d

Cleared Jun 20, 1997

RESISTICK SOLID LAPAROSCOPIC ELECTRODES

K971621 · Aaron Medical Industries

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 50d

Cleared Jun 13, 1997

NYLON COATED SPECULA

K925501 · Zinnanti Surgical Instruments, Inc.

HIB · Speculum, Vaginal, Nonmetal · 1687d

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