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
901–925 of 1727
Cleared Apr 24, 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
K020954 · Ackrad Laboratories
LKF · Cannula, Manipulator/injector, Uterine · 30d
Cleared Apr 17, 2002
TAMPONADE UTERINE BALLOON CATHETER SET
K013597 · Cook Ob/Gyn
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 168d
Cleared Apr 16, 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951 · Ackrad Laboratories
LKF · Cannula, Manipulator/injector, Uterine · 22d
Cleared Mar 05, 2002
TROJAN PASSION BERRY GEL
K013433 · Armkel, LLC
NUC · Lubricant, Personal · 140d
Cleared Feb 08, 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc.
MQG · Accessory, Assisted Reproduction · 51d
Cleared Feb 01, 2002
TROJAN CRYSTAL CLEAR LIQUID
K013614 · Armkel, LLC
NUC · Lubricant, Personal · 88d
Cleared Jan 18, 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
K013518 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 87d
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 57d
Cleared Nov 13, 2001
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 90d
Cleared Oct 23, 2001
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 288d
Cleared Aug 27, 2001
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
K002328 · Richard Wolf Medical Instruments Corp.
HIF · Insufflator, Laparoscopic · 391d
Cleared Aug 15, 2001
AMEDA HYGIENIKIT
K011519 · Hollister, Inc.
HGY · Pump, Breast, Non-powered · 90d
Cleared Jul 18, 2001
OIL FOR EMBRYO CULTURE
K011938 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 27d
Cleared Jul 09, 2001
US SENSOR #CG-930P
K003876 · Card Guard Scientific Survival , Ltd.
HEL · Monitor, Heart Rate, Fetal, Ultrasonic · 206d
Cleared Jun 13, 2001
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
K011598 · Irvine Scientific Sales Co., Inc.
MTW · System, Water, Reproduction, Assisted, And Purification · 20d
Cleared Jun 11, 2001
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752 · Aesculap, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 90d
Cleared May 11, 2001
CG-900P FETAL/MATERNAL MONITOR
K010552 · Card Guard Scientific Survival , Ltd.
HGM · System, Monitoring, Perinatal · 74d
Cleared May 03, 2001
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · Cook Urological, Inc.
MQL · Media, Reproductive · 17d
Cleared Apr 09, 2001
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
K010931 · American Medical Systems, Inc.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 12d
Cleared Apr 04, 2001
MINI FIBER ENDOSCOPES
K003417 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 153d
Cleared Mar 02, 2001
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
K000180 · Richard Wolf Medical Instruments Corp.
HIF · Insufflator, Laparoscopic · 407d
Cleared Feb 21, 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · Stryker Corp.
HIF · Insufflator, Laparoscopic · 75d
Cleared Feb 20, 2001
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
K003608 · Aesculap, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 90d
Cleared Jan 17, 2001
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
K003278 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 90d
Cleared Jan 08, 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 90d

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All categories 1727 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 MQL Media, Reproductive 121 NUC Lubricant, Personal 121 HIH Hysteroscope (and Accessories) 106 HEB Tampon, Menstrual, Unscented 100 HGM System, Monitoring, Perinatal 86 HIF Insufflator, Laparoscopic 80 HHD Pad, Menstrual, Unscented 54 LKF Cannula, Manipulator/injector, Uterine 43 HHL Pad, Menstrual, Scented, Scented-deodorized 38 HIS Condom 37 HIG Insufflator, Hysteroscopic 27 MQF Catheter, Assisted Reproduction 24 OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 24