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
3148 Obstetrics & Gynecology devices
Cleared
May 17, 2019
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
MQF
Catheter, Assisted Reproduction
30d
Cleared
May 16, 2019
Aveta System
HIH
Hysteroscope (and Accessories)
90d
Cleared
May 15, 2019
Endosee System
HIH
Hysteroscope (and Accessories)
63d
Cleared
May 10, 2019
Hysteroscope System
HIH
Hysteroscope (and Accessories)
332d
Cleared
May 10, 2019
Wallace Dual Lumen Oocyte Recovery System
MQE
Needle, Assisted Reproduction
197d
Cleared
May 09, 2019
Unscented Menstrual Tampon
HEB
Tampon, Menstrual, Unscented
94d
Cleared
May 08, 2019
Gynescope System
HEX
Colposcope (and Colpomicroscope)
96d
Cleared
Apr 26, 2019
JO Actively Trying Personal Lubricant
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
218d
Cleared
Apr 25, 2019
Smile Makers Personal Lubricant
NUC
Lubricant, Personal
265d
Cleared
Apr 24, 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
HIH
Hysteroscope (and Accessories)
90d
Cleared
Apr 17, 2019
JO H2O Jelly Original Personal Lubricant
NUC
Lubricant, Personal
117d
Cleared
Apr 16, 2019
KY Banksy Aloe
NUC
Lubricant, Personal
140d
Cleared
Apr 15, 2019
One Touch
HIS
Condom
278d
Cleared
Mar 29, 2019
Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
LKF
Cannula, Manipulator/injector, Uterine
269d
Cleared
Mar 15, 2019
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
HEB
Tampon, Menstrual, Unscented
163d
Cleared
Mar 07, 2019
Electric Breast Pump
HGX
Pump, Breast, Powered
184d
Cleared
Mar 04, 2019
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
NUC
Lubricant, Personal
88d
Cleared
Mar 01, 2019
Fetal Doppler, Model FD88
KNG
Monitor, Ultrasonic, Fetal
155d
Cleared
Jan 31, 2019
Endosee System
HIH
Hysteroscope (and Accessories)
91d
Cleared
Jan 04, 2019
Rapid-i™ Kit
MQK
Labware, Assisted Reproduction
214d
Cleared
Jan 04, 2019
Polygon Resection Device
HIH
Hysteroscope (and Accessories)
100d
Cleared
Dec 21, 2018
Creme de La Femme Feminine Lubricant
NUC
Lubricant, Personal
353d
Cleared
Dec 20, 2018
Natureplex Warm Touch Warming Jelly
NUC
Lubricant, Personal
265d
Cleared
Dec 19, 2018
Fetal Doppler
KNG
Monitor, Ultrasonic, Fetal
128d
Cleared
Dec 06, 2018
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
HIH
Hysteroscope (and Accessories)
132d
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