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
Feb 15, 2000
REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
HIS
Condom
130d
Cleared
Feb 15, 2000
REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
HIS
Condom
130d
Cleared
Feb 15, 2000
REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
HIS
Condom
130d
Cleared
Feb 15, 2000
REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
HIS
Condom
130d
Cleared
Feb 15, 2000
REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
HIS
Condom
130d
Cleared
Feb 14, 2000
REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT
HIS
Condom
129d
Cleared
Feb 14, 2000
GENX CULTURE DISH
MQK
Labware, Assisted Reproduction
90d
Cleared
Feb 14, 2000
GENX MICROTOOLS
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
90d
Cleared
Feb 07, 2000
HUMAN SERUM ALBUMIN
MQL
Media, Reproductive
292d
Cleared
Feb 07, 2000
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
HEB
Tampon, Menstrual, Unscented
90d
Cleared
Feb 07, 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
HET
Laparoscope, Gynecologic (and Accessories)
90d
Cleared
Feb 07, 2000
KSEA RIGID CULDOSCOPE AND ACCESSORIES
HEW
Culdoscope (and Accessories)
90d
Cleared
Feb 02, 2000
QUINN'S SPERM WASHING MEDIUM
MQL
Media, Reproductive
287d
Cleared
Feb 02, 2000
HYALURONIDASE, 80 U/ML
MQL
Media, Reproductive
287d
Cleared
Feb 02, 2000
COROMETRICS MODEL 173 FETAL MONITOR
HGM
System, Monitoring, Perinatal
89d
Cleared
Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
HIS
Condom
86d
Cleared
Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
HIS
Condom
86d
Cleared
Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)
HIS
Condom
86d
Cleared
Jan 24, 2000
BABY DOPPLEX 4000, MODEL BD 4000
HGM
System, Monitoring, Perinatal
335d
Cleared
Jan 24, 2000
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
HFW
Clamp, Umbilical
38d
Cleared
Jan 24, 2000
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
HIH
Hysteroscope (and Accessories)
26d
Cleared
Jan 18, 2000
1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
MQL
Media, Reproductive
272d
Cleared
Jan 18, 2000
GYNECARE VERSAPOINT G-VAP ELECTRODE
HIH
Hysteroscope (and Accessories)
141d
Cleared
Jan 18, 2000
UNSCENTED INTERLABIAL MENSTRUAL PAD
HHD
Pad, Menstrual, Unscented
64d
Cleared
Jan 18, 2000
LATEX CONDOM
HIS
Condom
46d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices