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
Cleared
Aug 13, 2010
SPECTRA SERIES BREAST PUMP
HGX
Pump, Breast, Powered
312d
Cleared
Aug 06, 2010
SEILER COLPOSCOPE, MODELS 935, 955 AND 985
HEX
Colposcope (and Colpomicroscope)
106d
Cleared
Jul 26, 2010
THE PANPAC SUCTION CURETTE
HHK
Curette, Suction, Endometrial (and Accessories)
301d
Cleared
Jul 26, 2010
PHILIPS OBTRACEVUE MODEL SW REV. G.00
HGM
System, Monitoring, Perinatal
160d
Cleared
Jul 23, 2010
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
HIG
Insufflator, Hysteroscopic
388d
Cleared
Jul 22, 2010
PANPAC VAGINAL PESSARY
HHW
Pessary, Vaginal
297d
Cleared
Jul 14, 2010
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
HGX
Pump, Breast, Powered
231d
Cleared
Jul 09, 2010
ECLERIS MICROSTAR COLPOSCOPE
HEX
Colposcope (and Colpomicroscope)
129d
Cleared
Jun 28, 2010
BELLECUP
HHE
Cup, Menstrual
273d
Cleared
Jun 24, 2010
VASOVAPOR
HIF
Insufflator, Laparoscopic
44d
Cleared
Jun 16, 2010
UNIMOM ALLEGRO
HGX
Pump, Breast, Powered
72d
Cleared
Jun 15, 2010
VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
MQL
Media, Reproductive
336d
Cleared
Jun 07, 2010
PANPAC HSG CATHETER SET
LKF
Cannula, Manipulator/injector, Uterine
252d
Cleared
Jun 03, 2010
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
MQL
Media, Reproductive
276d
Cleared
Jun 01, 2010
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
HEB
Tampon, Menstrual, Unscented
396d
Cleared
May 28, 2010
AMEDA PLATINUM BREAST PUMP
HGX
Pump, Breast, Powered
101d
Cleared
May 18, 2010
FEMEYE TWO
HIH
Hysteroscope (and Accessories)
217d
Cleared
May 12, 2010
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
HIS
Condom
261d
Cleared
May 07, 2010
HYALO GYN
NUC
Lubricant, Personal
128d
Cleared
Apr 30, 2010
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
OQY
Intrauterine Tamponade Balloon
303d
Cleared
Apr 30, 2010
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
MQH
Microtools, Assisted Reproduction (pipettes)
253d
Cleared
Apr 30, 2010
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
LKF
Cannula, Manipulator/injector, Uterine
217d
Cleared
Apr 29, 2010
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
HDA
Forceps, Obstetrical
65d
Cleared
Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
NAJ
Agents, Embolic, For Treatment Of Uterine Fibroids
39d
Cleared
Apr 14, 2010
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
113d
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