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
Dec 13, 2002
SPERM WASH MEDIUM WITH GENTAMICIN
MQL
Media, Reproductive
38d
Cleared
Dec 12, 2002
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
LKF
Cannula, Manipulator/injector, Uterine
90d
Cleared
Dec 12, 2002
UNIDUS MALE LATEX CONDOM
HIS
Condom
90d
Cleared
Dec 11, 2002
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
MQF
Catheter, Assisted Reproduction
64d
Cleared
Dec 06, 2002
O.B. TAMPONS
HEB
Tampon, Menstrual, Unscented
23d
Cleared
Dec 02, 2002
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
HGX
Pump, Breast, Powered
89d
Cleared
Nov 26, 2002
SAFETOUCH
NHM
Sheet, Recording, Breast Examination
90d
Cleared
Nov 26, 2002
ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
MQL
Media, Reproductive
75d
Cleared
Nov 26, 2002
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
40d
Cleared
Nov 22, 2002
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
NAJ
Agents, Embolic, For Treatment Of Uterine Fibroids
204d
Cleared
Nov 08, 2002
PNEUMOPERITONEUM INSUFFLATION NEEDLE
HIF
Insufflator, Laparoscopic
203d
Cleared
Nov 08, 2002
SPERM CRYOPROTEC
MQL
Media, Reproductive
44d
Cleared
Nov 05, 2002
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
MQH
Microtools, Assisted Reproduction (pipettes)
89d
Cleared
Nov 05, 2002
PROMOTOR
MQL
Media, Reproductive
48d
Cleared
Nov 04, 2002
HYALURONIDASE SOLUTION
MQL
Media, Reproductive
61d
Cleared
Nov 04, 2002
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
HIB
Speculum, Vaginal, Nonmetal
60d
Cleared
Nov 01, 2002
THOMAS MEDICAL ELECTRODES
HGI
Electrocautery, Gynecologic (and Accessories)
88d
Cleared
Nov 01, 2002
PLAYTEX BREAST PUMP
HGX
Pump, Breast, Powered
88d
Cleared
Oct 25, 2002
SENSUA!
HIS
Condom
200d
Cleared
Oct 25, 2002
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
HIS
Condom
193d
Cleared
Oct 25, 2002
DFV CPG COLPOSCOPE
HEX
Colposcope (and Colpomicroscope)
141d
Cleared
Oct 25, 2002
UTERINE INJECTOR
LKF
Cannula, Manipulator/injector, Uterine
88d
Cleared
Oct 18, 2002
XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
HET
Laparoscope, Gynecologic (and Accessories)
88d
Cleared
Oct 09, 2002
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
HET
Laparoscope, Gynecologic (and Accessories)
51d
Cleared
Sep 30, 2002
WHISPER WEAR BREAST PUMP
HGX
Pump, Breast, Powered
90d
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