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

1176–1200 of 1727

Cleared Jun 21, 1994

ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)

K940505 · Uresil Corp.

HET · Laparoscope, Gynecologic (and Accessories) · 138d

Cleared Jun 14, 1994

MX4042/MC4044 SERIES SIMULCATH(TM)

K922323 · Medex, Inc.

KXO · Monitor, Pressure, Intrauterine · 771d

Cleared Jun 14, 1994

CONTINUOUS FLOW HYSTERO-RESECTOSCOPE

K922420 · Linvatec Corp.

HIH · Hysteroscope (and Accessories) · 754d

Cleared Jun 14, 1994

DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE

K941334 · Davol, Inc.

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

Cleared Jun 08, 1994

HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

K931764 · Olympus Corp.

HIH · Hysteroscope (and Accessories) · 426d

Cleared Jun 07, 1994

SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE

K925957 · Zinnanti Surgical Instruments, Inc.

HFI · Coagulator, Culdoscopic (and Accessories) · 560d

Cleared Jun 07, 1994

FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE

K925960 · Zinnanti Surgical Instruments, Inc.

HFI · Coagulator, Culdoscopic (and Accessories) · 560d

Cleared May 27, 1994

OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT

K935434 · United States Surgical, A Division of Tyco Healthc

LKF · Cannula, Manipulator/injector, Uterine · 198d

Cleared May 19, 1994

SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS

K940709 · Baxter Healthcare Corp

HET · Laparoscope, Gynecologic (and Accessories) · 91d

Cleared May 16, 1994

CABOT MEDICAL UTERINE RESECTOSCOPE

K924631 · Cabot Medical Corp.

HIH · Hysteroscope (and Accessories) · 609d

Cleared May 12, 1994

PEARL PACKING FORCEPS

K941528 · Cook Urological, Inc.

HCZ · Forceps, Surgical, Gynecological · 43d

Cleared May 11, 1994

KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES

K935785 · KARL STORZ Endoscopy-America, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 156d

Cleared May 10, 1994

KARL STORZ ELECTRONIC LAPAROFLATOR

K934043 · KARL STORZ Endoscopy-America, Inc.

HIF · Insufflator, Laparoscopic · 264d

Cleared May 10, 1994

KARL STORZ ELECTRONIC LAPAROFLATOR

K934114 · KARL STORZ Endoscopy-America, Inc.

HIF · Insufflator, Laparoscopic · 258d

Cleared May 10, 1994

HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION

K940462 · KARL STORZ Endoscopy-America, Inc.

HET · Laparoscope, Gynecologic (and Accessories) · 97d

Cleared May 06, 1994

KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS

K940049 · Baxter Healthcare Corp

HET · Laparoscope, Gynecologic (and Accessories) · 121d

Cleared May 02, 1994

MYOMA DRILL 5MM-8383.611

K940844 · Richard Wolf Medical Instruments Corp.

HET · Laparoscope, Gynecologic (and Accessories) · 68d

Cleared Apr 28, 1994

K925968 · United States Surgical, A Division of Tyco Healthc

HET · Laparoscope, Gynecologic (and Accessories) · 519d

Cleared Apr 19, 1994

K931630 · Cook Ob/Gyn

MFD · Cannula, Intrauterine Insemination · 382d

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 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

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