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
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 10, 2011
K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
NUC
Lubricant, Personal
337d
Cleared
May 06, 2011
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
281d
Cleared
May 05, 2011
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
HGM
System, Monitoring, Perinatal
268d
Cleared
Apr 28, 2011
FEMVUE SALINE-AIR DEVICE
LKF
Cannula, Manipulator/injector, Uterine
86d
Cleared
Apr 19, 2011
INJECTION PIPETTE
MQH
Microtools, Assisted Reproduction (pipettes)
232d
Cleared
Apr 14, 2011
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
HHK
Curette, Suction, Endometrial (and Accessories)
197d
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 18, 2011
PHILIPS AVALON FETAL MONITOR
HGM
System, Monitoring, Perinatal
165d
Cleared
Mar 11, 2011
LINA XCISE MODEL MOR-1515
HET
Laparoscope, Gynecologic (and Accessories)
289d
Cleared
Mar 11, 2011
CIV-OB (PLUS)
HGM
System, Monitoring, Perinatal
134d
Cleared
Mar 11, 2011
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
35d
Cleared
Mar 10, 2011
DYSIS
HEX
Colposcope (and Colpomicroscope)
580d
Cleared
Mar 01, 2011
TROKAMED MORCELLATOR
HET
Laparoscope, Gynecologic (and Accessories)
691d
Cleared
Feb 24, 2011
BILLY BOY MALE LATEX CONDOM
HIS
Condom
125d
Cleared
Feb 08, 2011
HEAL FORCE CO2 INCUBATOR
MQG
Accessory, Assisted Reproduction
209d
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