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
Apr 26, 2002
MALE LATEX CONDOM WITH RIBBED SURFACE
HIS
Condom
88d
Cleared
Apr 24, 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
LKF
Cannula, Manipulator/injector, Uterine
30d
Cleared
Apr 19, 2002
MODIFICATION TO FETAL ASSIST
LQK
Home Uterine Activity Monitor
72d
Cleared
Apr 18, 2002
VERSALAB APM
HGM
System, Monitoring, Perinatal
198d
Cleared
Apr 17, 2002
TAMPONADE UTERINE BALLOON CATHETER SET
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
168d
Cleared
Apr 17, 2002
UTERINE INJECTOR
LKF
Cannula, Manipulator/injector, Uterine
79d
Cleared
Apr 16, 2002
H/S CATHETER SET (5F), MODEL 61-5005
LKF
Cannula, Manipulator/injector, Uterine
22d
Cleared
Apr 12, 2002
MITYVAC MERLIN, MODEL 10027
HDB
Extractor, Vacuum, Fetal
60d
Cleared
Apr 02, 2002
MULTI HI-FLO PNEU, WISAP #7080
HIF
Insufflator, Laparoscopic
321d
Cleared
Mar 29, 2002
DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
HIS
Condom
28d
Cleared
Mar 28, 2002
PBS, PBSW WITH CATIONS AND PHENOL RED
MQL
Media, Reproductive
43d
Cleared
Mar 25, 2002
JOE LUBE CONDOM
HIS
Condom
326d
Cleared
Mar 25, 2002
JOE LUB HELMET CONDOM
HIS
Condom
326d
Cleared
Mar 21, 2002
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
85d
Cleared
Mar 13, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34802
HIL
Tampon, Menstrual, Scented, Scented-deodorized
50d
Cleared
Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34902
HIL
Tampon, Menstrual, Scented, Scented-deodorized
49d
Cleared
Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34702
HIL
Tampon, Menstrual, Scented, Scented-deodorized
49d
Cleared
Mar 11, 2002
GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
HIH
Hysteroscope (and Accessories)
196d
Cleared
Mar 07, 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
HGX
Pump, Breast, Powered
16d
Cleared
Mar 05, 2002
TROJAN PASSION BERRY GEL
NUC
Lubricant, Personal
140d
Cleared
Mar 04, 2002
INVIGRA
HIS
Condom
41d
Cleared
Mar 01, 2002
DRG DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
206d
Cleared
Mar 01, 2002
SAFETOUCH
NHM
Sheet, Recording, Breast Examination
60d
Cleared
Feb 22, 2002
SPIRABRUSH CX BIOPSY INSTRUMENT
HFB
Forceps, Biopsy, Gynecological
283d
Cleared
Feb 20, 2002
VASOVIEW 5 HARVESTING CANNULA
HET
Laparoscope, Gynecologic (and Accessories)
35d
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