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
Jan 10, 2018
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
MQF
Catheter, Assisted Reproduction
188d
Cleared
Jan 04, 2018
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
HIH
Hysteroscope (and Accessories)
265d
Cleared
Dec 21, 2017
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
MQF
Catheter, Assisted Reproduction
142d
Cleared
Dec 20, 2017
Electric Breast Pump
HGX
Pump, Breast, Powered
84d
Cleared
Dec 15, 2017
Polyform Synthetic Mesh
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
228d
Cleared
Dec 15, 2017
Double Lumen Ovum Aspiration Needles
MQE
Needle, Assisted Reproduction
197d
Cleared
Dec 15, 2017
LifeStyles® SKYN® Intimate Moments Personal Lubricant
NUC
Lubricant, Personal
122d
Cleared
Dec 14, 2017
Vitrification Kit and Thawing Kit
MQL
Media, Reproductive
184d
Cleared
Dec 06, 2017
wettrust D2care
NUC
Lubricant, Personal
264d
Cleared
Nov 29, 2017
One Mum Pumpset
HGX
Pump, Breast, Powered
145d
Cleared
Nov 28, 2017
LAP-iX Suction Irrigation
HET
Laparoscope, Gynecologic (and Accessories)
60d
Cleared
Nov 21, 2017
Climax Personal Lubricant
NUC
Lubricant, Personal
228d
Cleared
Nov 21, 2017
Follicle Aspiration Set, Reduced Single Lumen
MQE
Needle, Assisted Reproduction
138d
Cleared
Nov 15, 2017
Geri Embryo Incubator and Geri Dish
MQG
Accessory, Assisted Reproduction
156d
Cleared
Nov 14, 2017
AP 50/30 Insufflator with Insuflow Port
HIF
Insufflator, Laparoscopic
242d
Cleared
Nov 03, 2017
Capio SLIM Suture Capturing Device
PWI
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
119d
Cleared
Oct 31, 2017
JO Gelato Flavored Personal Lubricants
NUC
Lubricant, Personal
78d
Cleared
Oct 13, 2017
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS
MQL
Media, Reproductive
84d
Cleared
Oct 13, 2017
Freemie Independence, Freemie Liberty
HGX
Pump, Breast, Powered
29d
Cleared
Oct 12, 2017
JUD custom fit condom
HIS
Condom
63d
Cleared
Oct 11, 2017
U by Kotex Click Unscented Menstrual Tampons
HEB
Tampon, Menstrual, Unscented
90d
Cleared
Oct 02, 2017
Yooeehouse Breast Pump
HGX
Pump, Breast, Powered
322d
Cleared
Sep 29, 2017
Berkeley VC-10 Vacuum Curettage System
HHI
System, Abortion, Vacuum
136d
Cleared
Sep 28, 2017
Gems Oocyte Retrieval Buffer ORB-20, ORB-50
MQL
Media, Reproductive
223d
Cleared
Sep 22, 2017
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
NUC
Lubricant, Personal
269d
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