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
3160 Obstetrics & Gynecology devices
Cleared
Jun 08, 1999
PRODIMED MICROINJECTION PIPETTES
MQH
Microtools, Assisted Reproduction (pipettes)
230d
Cleared
Jun 08, 1999
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
MQE
Needle, Assisted Reproduction
82d
Cleared
Jun 03, 1999
MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
HIH
Hysteroscope (and Accessories)
77d
Cleared
May 27, 1999
INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
MQF
Catheter, Assisted Reproduction
225d
Cleared
May 24, 1999
LACTATION TECHNIQUES MODEL B
HGX
Pump, Breast, Powered
389d
Cleared
May 24, 1999
BERACLAMP, MODEL BC-1
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
138d
Cleared
May 24, 1999
PELVX INCONTINENCE DISH, MODEL 301-306
HHW
Pessary, Vaginal
89d
Cleared
May 20, 1999
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
HGI
Electrocautery, Gynecologic (and Accessories)
202d
Cleared
May 17, 1999
CVS PERSONAL LUBRICANT
HIS
Condom
245d
Cleared
May 17, 1999
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
LTZ
Condom With Nonoxynol-9
76d
Cleared
May 11, 1999
MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
HIH
Hysteroscope (and Accessories)
90d
Cleared
May 05, 1999
FALCON IVF FOUR WELL PLATE
MQK
Labware, Assisted Reproduction
22d
Cleared
May 05, 1999
FALCON IVF ONE WELL DISH
MQK
Labware, Assisted Reproduction
22d
Cleared
May 05, 1999
FALCON IVF ROUND DISH
MQK
Labware, Assisted Reproduction
22d
Cleared
Apr 26, 1999
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM
MQL
Media, Reproductive
195d
Cleared
Apr 26, 1999
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
HGX
Pump, Breast, Powered
182d
Cleared
Apr 23, 1999
SYNTHETIC SERUM SUBSTITUTE (SSS)
MQL
Media, Reproductive
192d
Cleared
Apr 20, 1999
ENDOMETRIAL SAMPLER
HHK
Curette, Suction, Endometrial (and Accessories)
71d
Cleared
Apr 16, 1999
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
HIN
Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
87d
Cleared
Apr 06, 1999
'ECURLINE UMBILICAL CORD CLAMP #3500
HFW
Clamp, Umbilical
32d
Cleared
Apr 02, 1999
DCI ENDOSCOPE
HET
Laparoscope, Gynecologic (and Accessories)
88d
Cleared
Mar 15, 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
LTZ
Condom With Nonoxynol-9
284d
Cleared
Mar 15, 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
HHT
Spatula, Cervical, Cytological
182d
Cleared
Mar 12, 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
HIS
Condom
361d
Cleared
Mar 12, 1999
GYNEX ELECTRODES
HGI
Electrocautery, Gynecologic (and Accessories)
218d
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