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
Feb 09, 2018
Meridian Vaginal Positioning System (VPS)
PWK
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
88d
Cleared
Feb 05, 2018
Flip Lube
NUC
Lubricant, Personal
257d
Cleared
Feb 05, 2018
Aquilex Fluid Control System AQL-100S
HIG
Insufflator, Hysteroscopic
215d
Cleared
Jan 18, 2018
Flex Robotic System and Flex Transabdominal Drive
HET
Laparoscope, Gynecologic (and Accessories)
125d
Cleared
Jan 12, 2018
One Touch Condom with Benzocaine
HIS
Condom
262d
Cleared
Jan 12, 2018
Single Lumen Ovum Aspiration Needles
MQE
Needle, Assisted Reproduction
224d
Cleared
Jan 12, 2018
K-Y Silicone
NUC
Lubricant, Personal
60d
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
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