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
3150 Obstetrics & Gynecology devices
Cleared
May 15, 2014
FETAL MONITORS
HGM
System, Monitoring, Perinatal
322d
Cleared
May 14, 2014
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
MQL
Media, Reproductive
142d
Cleared
May 13, 2014
VERSACUT + TISSUE MORCELLATOR
GCJ
Laparoscope, General & Plastic Surgery
201d
Cleared
May 07, 2014
Origio Gas Line Filter
MQG
Accessory, Assisted Reproduction
236d
Cleared
May 01, 2014
SUSTAIN
HIS
Condom
311d
Cleared
Apr 29, 2014
ORIGIO(R) SEQUENTIAL BLAST TM
MQL
Media, Reproductive
175d
Cleared
Apr 28, 2014
ACESSA GUIDANCE HANDPIECE
HFG
Coagulator, Laparoscopic, Unipolar (and Accessories)
287d
Cleared
Apr 28, 2014
BRELLA-SPEC(TM) VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
130d
Cleared
Apr 24, 2014
ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
223d
Cleared
Apr 23, 2014
EUM 100PRO
OSP
Uterine Electromyographic Monitor
302d
Cleared
Apr 23, 2014
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
HEB
Tampon, Menstrual, Unscented
247d
Cleared
Apr 23, 2014
XQ-1 INCUBATOR
MQG
Accessory, Assisted Reproduction
135d
Cleared
Apr 22, 2014
INSTINCT
HIS
Condom
264d
Cleared
Apr 21, 2014
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
HES
Insufflator, Carbon-dioxide, Uterotubal (and Accessories)
26d
Cleared
Apr 16, 2014
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
MQL
Media, Reproductive
133d
Cleared
Apr 11, 2014
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
HCZ
Forceps, Surgical, Gynecological
101d
Cleared
Apr 10, 2014
ONTEX AND OTHERS PROPRIETARY NAMES
HIL
Tampon, Menstrual, Scented, Scented-deodorized
268d
Cleared
Apr 08, 2014
THE GYNOCULAR
HEX
Colposcope (and Colpomicroscope)
246d
Cleared
Apr 03, 2014
CRYOTOP(R) SC
MQK
Labware, Assisted Reproduction
80d
Not Cleared
Mar 28, 2014
IOGYN SYSTEM
PGT
Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar
210d
Cleared
Mar 19, 2014
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
PGK
Cannula, Injector, Uterine, Endometrial Biopsy
153d
Cleared
Mar 07, 2014
MALE LATEX CONDOM
HIS
Condom
242d
Cleared
Mar 05, 2014
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
HIF
Insufflator, Laparoscopic
30d
Cleared
Feb 24, 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
NAJ
Agents, Embolic, For Treatment Of Uterine Fibroids
104d
Cleared
Feb 20, 2014
PROINSERT
MQK
Labware, Assisted Reproduction
303d
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