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
4478
Total
4465
Cleared
163d
Avg (2y)
1976
Since
849 Obstetrics & Gynecology devices
Cleared
Nov 06, 2020
Durex Penck Standard, Durex Penck XL
HIS
Condom
238d
Cleared
Nov 06, 2020
Aqueduct 100 Plus Cervical Dilation Balloon Catheter
PON
Catheter, Balloon, Dilation Of Cervical Canal
73d
Cleared
Oct 29, 2020
Visera Elite II Video System Center
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
48d
Cleared
Oct 23, 2020
BenestaTM Tissue Removal Device
HIH
Hysteroscope (and Accessories)
389d
Cleared
Oct 23, 2020
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
MQL
Media, Reproductive
263d
Cleared
Oct 21, 2020
EVA15
HIF
Insufflator, Laparoscopic
28d
Cleared
Oct 16, 2020
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
MQL
Media, Reproductive
240d
Cleared
Oct 13, 2020
Astroglide Organix Liquid
NUC
Lubricant, Personal
266d
Cleared
Oct 08, 2020
Schoelly Cystoscopes/Hysteroscopes and Accessories
HIH
Hysteroscope (and Accessories)
85d
Cleared
Oct 01, 2020
Philips Avent Single/Double electric breast pump Advanced
HGX
Pump, Breast, Powered
128d
Cleared
Sep 30, 2020
Allura Vaginal Stent
KXP
Stent, Vaginal
28d
Cleared
Sep 25, 2020
Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent
HIH
Hysteroscope (and Accessories)
88d
Cleared
Sep 18, 2020
LaborView™ LV1000 Wireless Electrode System
OSP
Uterine Electromyographic Monitor
540d
Cleared
Sep 11, 2020
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
HGX
Pump, Breast, Powered
273d
Cleared
Aug 28, 2020
Jada System
OQY
Intrauterine Tamponade Balloon
116d
Cleared
Aug 25, 2020
iMedium Single Step
MQL
Media, Reproductive
250d
Cleared
Aug 24, 2020
Intimate Rose Kegel Exercise System
HIR
Perineometer
264d
Cleared
Aug 21, 2020
4K UHD Camera System
HET
Laparoscope, Gynecologic (and Accessories)
206d
Cleared
Aug 20, 2020
Non-spermicidal Lubricated Male Latex Condom
HIS
Condom
241d
Cleared
Aug 17, 2020
Sperm Freeze, Sperm Fridge
MQL
Media, Reproductive
319d
Cleared
Aug 07, 2020
CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))
HIS
Condom
107d
Cleared
Aug 05, 2020
CrossGlide ETS Plus
HHK
Curette, Suction, Endometrial (and Accessories)
22d
Cleared
Jul 30, 2020
KY Grosz Jelly
NUC
Lubricant, Personal
90d
Cleared
Jul 29, 2020
PNEUMOCLEAR
HIF
Insufflator, Laparoscopic
68d
Cleared
Jul 24, 2020
Extremely Thin 003, ZERO ZERO THREE
HIS
Condom
303d
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