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
Mar 25, 2020
LaserShot M, NaviLase
MRX
System, Assisted Reproduction Laser
240d
Cleared
Mar 25, 2020
CrossBay Endometrial Tissue Sampler (ETS)
HHK
Curette, Suction, Endometrial (and Accessories)
191d
Cleared
Mar 18, 2020
Evolve Breast Pump
HGX
Pump, Breast, Powered
28d
Cleared
Mar 12, 2020
BioNourish Lubricant
NUC
Lubricant, Personal
90d
Cleared
Feb 25, 2020
PneumoLiner
PMU
Containment System, Laparoscopic Power Morcellation, With Instrument Port
137d
Cleared
Feb 13, 2020
Youjia Unscented Tampon with Plastic Applicators
HEB
Tampon, Menstrual, Unscented
149d
Cleared
Feb 10, 2020
JO for Him H2O Gel Original Personal Lubricant
NUC
Lubricant, Personal
180d
Cleared
Feb 06, 2020
Ah!Yes Ob Coco Personal Lubricant
NUC
Lubricant, Personal
254d
Cleared
Feb 05, 2020
Endosee System
HIH
Hysteroscope (and Accessories)
28d
Cleared
Jan 30, 2020
GTK Veress Needles
HIF
Insufflator, Laparoscopic
59d
Cleared
Jan 28, 2020
V-DENUPET
MQH
Microtools, Assisted Reproduction (pipettes)
173d
Cleared
Jan 22, 2020
Spectra Q
HGX
Pump, Breast, Powered
271d
Cleared
Jan 17, 2020
LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
HIH
Hysteroscope (and Accessories)
81d
Cleared
Jan 16, 2020
Resectr Tissue Resection Device
HIH
Hysteroscope (and Accessories)
220d
Cleared
Jan 16, 2020
Electric Breast Pump
HGX
Pump, Breast, Powered
197d
Cleared
Jan 14, 2020
G210 InviCell Plus with SignipHy pH monitoring
PUB
Accessory, Assisted Reproduction, Exempt
272d
Cleared
Jan 09, 2020
HyaloGYN Vaginal Moisturizing Suppositories
NUC
Lubricant, Personal
265d
Cleared
Dec 20, 2019
Unscented W long plastic and cardboard applicator tampons
HEB
Tampon, Menstrual, Unscented
182d
Cleared
Dec 19, 2019
Aveta Disposable Hysteroscope
HIH
Hysteroscope (and Accessories)
136d
Cleared
Dec 13, 2019
Satisfaite
NUC
Lubricant, Personal
263d
Cleared
Nov 25, 2019
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
MQE
Needle, Assisted Reproduction
263d
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
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