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
May 25, 1995
KSE STEINER ELECTROMECHANIC MORCELLATOR
HET
Laparoscope, Gynecologic (and Accessories)
160d
Cleared
May 25, 1995
LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000
KXO
Monitor, Pressure, Intrauterine
101d
Cleared
May 25, 1995
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
HIG
Insufflator, Hysteroscopic
84d
Cleared
May 25, 1995
KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR
HFW
Clamp, Umbilical
73d
Cleared
May 18, 1995
LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)
HIS
Condom
428d
Cleared
May 15, 1995
IMAGYN INTRAUTERINE INSEMINATION DEVICE
HDR
Cap, Cervical
208d
Cleared
May 15, 1995
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
HGM
System, Monitoring, Perinatal
104d
Cleared
May 11, 1995
NURTURE III
HGX
Pump, Breast, Powered
988d
Cleared
May 11, 1995
OP-PNEU ELECTRONIC CO2
HIF
Insufflator, Laparoscopic
413d
Cleared
May 11, 1995
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
HET
Laparoscope, Gynecologic (and Accessories)
132d
Cleared
May 11, 1995
R-MED MINI-RETRACTOR
HET
Laparoscope, Gynecologic (and Accessories)
120d
Cleared
May 11, 1995
COOK INSEMINATION CUP
HDR
Cap, Cervical
85d
Cleared
May 11, 1995
AMSINO DISPOSABLE VIGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
38d
Cleared
May 05, 1995
CMI VELVET TOUCH VACUUM EXTRACTOR
HDB
Extractor, Vacuum, Fetal
330d
Cleared
May 05, 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
HET
Laparoscope, Gynecologic (and Accessories)
165d
Cleared
May 05, 1995
CANNUAL AND TROCAR, SUPERPUBIC
HET
Laparoscope, Gynecologic (and Accessories)
91d
Cleared
May 04, 1995
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
HGI
Electrocautery, Gynecologic (and Accessories)
1115d
Cleared
May 04, 1995
EXTRA PROTECTION POLYURETHANE CONDOM
MOL
Condom, Synthetic
1064d
Cleared
May 04, 1995
VAGINAL CONTINENCE DEVICE
HHW
Pessary, Vaginal
815d
Cleared
May 04, 1995
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
HHW
Pessary, Vaginal
646d
Cleared
May 03, 1995
MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
HDB
Extractor, Vacuum, Fetal
264d
Cleared
May 01, 1995
ABACUS OB ULTRASOUNG COMPUTER SOFTWARE
HEM
Imager, Ultrasonic Obstetric-gynecologic
35d
Cleared
Apr 27, 1995
FUJINON VIDEO LAPORASCOPE
HIH
Hysteroscope (and Accessories)
644d
Cleared
Apr 25, 1995
COLPOSCOPES AND ACCESSORIES
HEX
Colposcope (and Colpomicroscope)
473d
Cleared
Apr 25, 1995
AESCULAP LAPAROSCOPES
HET
Laparoscope, Gynecologic (and Accessories)
320d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices