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
3151 Obstetrics & Gynecology devices
Cleared
Feb 12, 2014
RESTORELLE Y CONTOUR MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
27d
Cleared
Feb 07, 2014
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
HGM
System, Monitoring, Perinatal
165d
Cleared
Jan 31, 2014
LINA GOLD LOOP HC
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
205d
Cleared
Jan 24, 2014
FETAL ULTRASONIC MONITOR AND ACCESSORIES
KNG
Monitor, Ultrasonic, Fetal
249d
Cleared
Jan 17, 2014
IOB DISPOSABLE SPECULUM
HIB
Speculum, Vaginal, Nonmetal
143d
Cleared
Jan 10, 2014
PANPAC WORD/BARTHOLIN CATHETER
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
361d
Cleared
Jan 09, 2014
CRYOLOCK
MQK
Labware, Assisted Reproduction
470d
Cleared
Jan 09, 2014
TAMPAX M PLASTIC TAMPONS, UNSCENTED
HEB
Tampon, Menstrual, Unscented
79d
Cleared
Jan 03, 2014
FMWAND FERROMAGNETIC SURGICAL SYSTEM
HGI
Electrocautery, Gynecologic (and Accessories)
302d
Cleared
Dec 13, 2013
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
HIH
Hysteroscope (and Accessories)
165d
Cleared
Dec 11, 2013
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
LKF
Cannula, Manipulator/injector, Uterine
266d
Cleared
Nov 25, 2013
BLACK COLOURED CONDOM
HIS
Condom
98d
Cleared
Nov 22, 2013
SENSE-4BABY SYSTEM
HGM
System, Monitoring, Perinatal
66d
Cleared
Nov 08, 2013
K-Y BRAND LIQUIBEADS
NUC
Lubricant, Personal
483d
Cleared
Nov 07, 2013
CONCEIVE PLUS
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
181d
Cleared
Oct 24, 2013
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
HIS
Condom
121d
Cleared
Oct 09, 2013
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
30d
Cleared
Sep 27, 2013
THEYFIT MALE CONDOM
HIS
Condom
429d
Cleared
Sep 27, 2013
COOK CERVICAL RIPENING BALLOON
PFJ
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
151d
Cleared
Sep 27, 2013
MORCELLEX SIGMA GENERATOR
HET
Laparoscope, Gynecologic (and Accessories)
113d
Cleared
Sep 20, 2013
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
HIF
Insufflator, Laparoscopic
66d
Cleared
Sep 18, 2013
GC-3000E DIGITAL COLPOSCOPE
HEX
Colposcope (and Colpomicroscope)
413d
Cleared
Sep 13, 2013
SASMAR ORIGINAL, SASMAR CLASSIC
NUC
Lubricant, Personal
148d
Cleared
Sep 11, 2013
KITAZATO IUI CATHETER
MQF
Catheter, Assisted Reproduction
111d
Cleared
Sep 06, 2013
FREEMIE BREAST COLLECTION SYSTEM
HGX
Pump, Breast, Powered
206d
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