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
Nov 22, 2019
LEva Pelvic Digital Health System
HIR
Perineometer
92d
Cleared
Nov 19, 2019
Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,
NUC
Lubricant, Personal
97d
Cleared
Nov 18, 2019
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
HIH
Hysteroscope (and Accessories)
235d
Cleared
Nov 14, 2019
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
MQF
Catheter, Assisted Reproduction
255d
Cleared
Nov 14, 2019
HeraBEAT™ US
KNG
Monitor, Ultrasonic, Fetal
202d
Cleared
Nov 07, 2019
BioGenesis Fertility Lubricant
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
218d
Cleared
Nov 01, 2019
WV1 Endoscope
HET
Laparoscope, Gynecologic (and Accessories)
273d
Cleared
Nov 01, 2019
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
HIH
Hysteroscope (and Accessories)
71d
Cleared
Oct 30, 2019
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
OQY
Intrauterine Tamponade Balloon
173d
Cleared
Oct 18, 2019
Evolve Breast Pump
HGX
Pump, Breast, Powered
234d
Cleared
Oct 17, 2019
Freestyle Flex
HGX
Pump, Breast, Powered
119d
Cleared
Oct 11, 2019
Spectra Cashmere
HGX
Pump, Breast, Powered
158d
Cleared
Oct 11, 2019
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
NUC
Lubricant, Personal
129d
Cleared
Oct 07, 2019
Interlude Rolled Tampons in Plastic Applicator
HEB
Tampon, Menstrual, Unscented
131d
Cleared
Oct 01, 2019
Aveta System
HIH
Hysteroscope (and Accessories)
70d
Cleared
Sep 26, 2019
SepaSperm Washing Solution, SepaSperm Solution
MQL
Media, Reproductive
234d
Cleared
Sep 25, 2019
3D Visualization System
GCJ
Laparoscope, General & Plastic Surgery
271d
Cleared
Sep 25, 2019
Aloe Glide Lubricant
NUC
Lubricant, Personal
224d
Cleared
Sep 18, 2019
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
NUC
Lubricant, Personal
169d
Cleared
Sep 18, 2019
GM501 Mineral Oil
MQL
Media, Reproductive
98d
Cleared
Sep 13, 2019
NICO Myriad NOVUS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
88d
Cleared
Sep 06, 2019
Transvaginal Access Platform
HEW
Culdoscope (and Accessories)
115d
Cleared
Sep 06, 2019
Willow Wearable Breast Pump 2.0
HGX
Pump, Breast, Powered
84d
Cleared
Sep 05, 2019
GM501 Wash
MQL
Media, Reproductive
198d
Cleared
Aug 30, 2019
OPERA, OPERA eco
HGX
Pump, Breast, Powered
154d
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