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

4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
1951–1975 of 4525
Cleared May 07, 2001
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
K003405 · Highland / Marietta, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 187d
Cleared May 03, 2001
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
K003458 · Clinical Innovations, Inc.
HGP · Electrode, Circular (spiral), Scalp And Applicator · 177d
Cleared May 03, 2001
KOALA CLAMP
K010695 · Maternus, Inc.
HFW · Clamp, Umbilical · 56d
Cleared May 03, 2001
KILEJIAN CIRCUMCISOR
K010867 · Iris Surgical, LLC
HFX · Clamp, Circumcision · 42d
Cleared May 03, 2001
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · Cook Urological, Inc.
MQL · Media, Reproductive · 17d
Cleared May 02, 2001
GLOBAL BY BLASTOCYST MEDIA
K010183 · Intl., Inc.
MQL · Media, Reproductive · 103d
Cleared Apr 30, 2001
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
K010835 · Busse Hospital Disposables, Inc.
HFW · Clamp, Umbilical · 41d
Cleared Apr 27, 2001
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K010178 · Innolatex Sdn. Bhd
LTZ · Condom With Nonoxynol-9 · 98d
Cleared Apr 27, 2001
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
K010371 · Suretex, Ltd.
HIS · Condom · 79d
Cleared Apr 27, 2001
SONICAID SYSTEM 8002
K992607 · Oxford Instruments Medical Systems
HGM · System, Monitoring, Perinatal · 633d
Cleared Apr 25, 2001
BABY DOPPLEX 3000 MK 2 (BD3000)
K010889 · Huntleigh Healthcare, Inc.
HGM · System, Monitoring, Perinatal · 30d
Cleared Apr 25, 2001
BABY DOPPLEX 3002 (BD3002)
K010894 · Huntleigh Healthcare, Inc.
HGM · System, Monitoring, Perinatal · 30d
Cleared Apr 11, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
K010296 · Marina Medical Instruments, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 70d
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 06, 2001
TCOYF FERTILITY SOFTWARE VERSION 1.0
K002726 · Ovusoft, LLC
LHD · Device, Fertility Diagnostic, Proceptive · 218d
Cleared Apr 05, 2001
PJUR EROS WATER FORMULATION
K010199 · L.C.C. Pjur Group Germany
NUC · Lubricant, Personal · 73d
Cleared Apr 04, 2001
MINI FIBER ENDOSCOPES
K003417 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 153d
Cleared Mar 30, 2001
SHEER THIN AROMAS RED LATEX CONDOM
K010028 · Eagle Twe, Inc.
HIS · Condom · 86d
Cleared Mar 29, 2001
SHEER THIN AROMAS YELLOW LATEX CONDOM
K004051 · Eagle Twe, Inc.
HIS · Condom · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS BLUE LATEX CONDOM
K004016 · Eagle Twe, Inc.
HIS · Condom · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS GREEN LATEX CONDOM
K004036 · Eagle Twe, Inc.
HIS · Condom · 89d
Cleared Mar 22, 2001
BLASTASSIST SYSTEM
K003156 · Medicult A/S
MQL · Media, Reproductive · 163d
Cleared Mar 22, 2001
SYNVITRO FLUSH
K003163 · Medicult A/S
MQL · Media, Reproductive · 163d
Cleared Mar 22, 2001
SUPRASPERM SYSTEM
K003404 · Medicult A/S
MQL · Media, Reproductive · 141d
Cleared Mar 21, 2001
WHITTLESTONE BREASTPUMP
K002696 · Whittlestone, Inc.
HGX · Pump, Breast, Powered · 203d

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All categories 4525 HIS Condom 401 HET Laparoscope, Gynecologic (and Accessories) 335 MQL Media, Reproductive 259 HGX Pump, Breast, Powered 254 NUC Lubricant, Personal 249 HGM System, Monitoring, Perinatal 209 HEB Tampon, Menstrual, Unscented 189 HIF Insufflator, Laparoscopic 177 HIH Hysteroscope (and Accessories) 173 HHD Pad, Menstrual, Unscented 136 LKF Cannula, Manipulator/injector, Uterine 87 HIL Tampon, Menstrual, Scented, Scented-deodorized 84 HIB Speculum, Vaginal, Nonmetal 72 HHT Spatula, Cervical, Cytological 70 KNA Instrument, Manual, Specialized Obstetric-gynecologic 58