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
4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3162 Obstetrics & Gynecology devices
Cleared
Apr 22, 1997
CARD GUARD MODEL CG-900
HGM
System, Monitoring, Perinatal
439d
Cleared
Apr 22, 1997
IMT LOUPE-COLPOSCOPE
HEX
Colposcope (and Colpomicroscope)
225d
Cleared
Apr 21, 1997
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
HET
Laparoscope, Gynecologic (and Accessories)
17d
Cleared
Apr 18, 1997
QFC UMBILICAL CLAMP
HFW
Clamp, Umbilical
204d
Cleared
Apr 09, 1997
PAP BRUSH
HHT
Spatula, Cervical, Cytological
198d
Cleared
Apr 09, 1997
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
LKF
Cannula, Manipulator/injector, Uterine
58d
Cleared
Apr 09, 1997
FEMTEX 100% COTTON TAMPONS
HEB
Tampon, Menstrual, Unscented
78d
Cleared
Apr 04, 1997
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
HET
Laparoscope, Gynecologic (and Accessories)
240d
Cleared
Apr 03, 1997
HARMONIES MENSTRUAL TAMPON
HEB
Tampon, Menstrual, Unscented
80d
Cleared
Apr 01, 1997
UMBILICAL CLAMP AND CUTTER
HFW
Clamp, Umbilical
214d
Cleared
Mar 28, 1997
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
142d
Cleared
Mar 28, 1997
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
HDB
Extractor, Vacuum, Fetal
78d
Cleared
Mar 21, 1997
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
HEB
Tampon, Menstrual, Unscented
59d
Cleared
Mar 21, 1997
TUSTEX FLAVORED CONDOMS
HIS
Condom
29d
Cleared
Mar 20, 1997
CANNULA
HET
Laparoscope, Gynecologic (and Accessories)
87d
Cleared
Mar 19, 1997
WALLACH INTEGRATION UNIT
HGI
Electrocautery, Gynecologic (and Accessories)
205d
Cleared
Mar 18, 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
HET
Laparoscope, Gynecologic (and Accessories)
62d
Cleared
Mar 11, 1997
QUANTITATIVE SENTINEL SYSTEM
HGM
System, Monitoring, Perinatal
182d
Cleared
Mar 10, 1997
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
HHW
Pessary, Vaginal
83d
Cleared
Mar 06, 1997
ROLLER ELECTRODE
HIH
Hysteroscope (and Accessories)
526d
Cleared
Mar 06, 1997
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
HET
Laparoscope, Gynecologic (and Accessories)
78d
Cleared
Mar 06, 1997
MEDLINE CIRCUMCISION TRAY
HFX
Clamp, Circumcision
41d
Cleared
Mar 04, 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
HET
Laparoscope, Gynecologic (and Accessories)
50d
Cleared
Feb 21, 1997
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
HGM
System, Monitoring, Perinatal
86d
Cleared
Feb 20, 1997
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
HEB
Tampon, Menstrual, Unscented
64d
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