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
3152 Obstetrics & Gynecology devices
Cleared
Jul 19, 2011
MINI TELEMETRY SYSTEM
HGM
System, Monitoring, Perinatal
141d
Cleared
Jul 19, 2011
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
HIG
Insufflator, Hysteroscopic
113d
Cleared
Jul 01, 2011
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
71d
Cleared
Jun 24, 2011
VIBERECT PENILE VIBRATORY STIMULATION DEVICE
KXQ
Vibrator For Therapeutic Use, Genital
116d
Cleared
Jun 24, 2011
F10
KNG
Monitor, Ultrasonic, Fetal
113d
Cleared
Jun 03, 2011
BILLY BOY MALE LATEX CONDOM
HIS
Condom
45d
Cleared
Jun 02, 2011
TAMPAX C PLASTIC TAMPONS, UNSCENTED
HEB
Tampon, Menstrual, Unscented
85d
Cleared
May 25, 2011
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
HIF
Insufflator, Laparoscopic
159d
Cleared
May 13, 2011
BT-350
HGM
System, Monitoring, Perinatal
162d
Cleared
May 06, 2011
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
281d
Cleared
Apr 28, 2011
FEMVUE SALINE-AIR DEVICE
LKF
Cannula, Manipulator/injector, Uterine
86d
Cleared
Apr 08, 2011
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
HEX
Colposcope (and Colpomicroscope)
80d
Cleared
Apr 05, 2011
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
MOL
Condom, Synthetic
383d
Cleared
Apr 01, 2011
ALYTE Y-MESH GRAFT
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
287d
Cleared
Mar 30, 2011
TRUCLEAR MORCELLATOR SYSTEM
HIH
Hysteroscope (and Accessories)
83d
Cleared
Mar 25, 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
HIH
Hysteroscope (and Accessories)
127d
Cleared
Mar 11, 2011
LINA XCISE MODEL MOR-1515
HET
Laparoscope, Gynecologic (and Accessories)
289d
Cleared
Mar 11, 2011
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
35d
Cleared
Jan 14, 2011
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
MQL
Media, Reproductive
476d
Cleared
Jan 13, 2011
FETAL MONITORS, MODELS F2 AND F3
HGM
System, Monitoring, Perinatal
168d
Not Cleared
Jan 13, 2011
HEM-AVERT PERIANAL STABILIZER
OOA
Hemorrhoid Prevention Pressure Wedge
513d
Cleared
Jan 11, 2011
BT-CATH
OQY
Intrauterine Tamponade Balloon
222d
Cleared
Jan 06, 2011
CENTRAL MONITORING SYSTEM
HGM
System, Monitoring, Perinatal
328d
Cleared
Dec 10, 2010
RAPIDVIT BLAST, RAPIDWARM BLAST
MQL
Media, Reproductive
242d
Cleared
Dec 10, 2010
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
HEB
Tampon, Menstrual, Unscented
30d
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