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
Apr 20, 2018
JO H2O Flavored Personal Lubricants
NUC
Lubricant, Personal
85d
Cleared
Apr 20, 2018
Geri Embryo Incubator and Geri Dish
MQG
Accessory, Assisted Reproduction
77d
Cleared
Apr 19, 2018
SuperSlyde Personal Lubricant
NUC
Lubricant, Personal
262d
Cleared
Apr 16, 2018
GDT-1000 System
HIH
Hysteroscope (and Accessories)
90d
Cleared
Apr 13, 2018
Pivet and Soft-Pass Embryo Transfer Catheter Sets
MQF
Catheter, Assisted Reproduction
196d
Cleared
Apr 11, 2018
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
MQF
Catheter, Assisted Reproduction
131d
Cleared
Apr 09, 2018
Hysteroscopy System
HGH
Cannula, Suction, Uterine
266d
Cleared
Apr 09, 2018
Silicone Personal Lubricant, ALL-IN-ONE
NUC
Lubricant, Personal
88d
Cleared
Apr 04, 2018
The Pump by Babyation
HGX
Pump, Breast, Powered
121d
Cleared
Mar 28, 2018
GYN-Pump PH304
HIG
Insufflator, Hysteroscopic
135d
Cleared
Mar 16, 2018
SurgiQuest AIRSEAL iFS System
HIF
Insufflator, Laparoscopic
207d
Cleared
Mar 14, 2018
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
HIS
Condom
57d
Cleared
Mar 14, 2018
Advincula Delineator Uterine Manipulator
HEW
Culdoscope (and Accessories)
26d
Cleared
Mar 08, 2018
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
MQK
Labware, Assisted Reproduction
160d
Cleared
Mar 02, 2018
ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)
MQL
Media, Reproductive
98d
Cleared
Mar 02, 2018
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
MQL
Media, Reproductive
86d
Cleared
Feb 15, 2018
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
LKF
Cannula, Manipulator/injector, Uterine
259d
Cleared
Feb 14, 2018
TEMED Gas Diffuser
HIF
Insufflator, Laparoscopic
90d
Cleared
Feb 12, 2018
Digitex Delivery Device
PWI
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
90d
Cleared
Feb 09, 2018
Tosama Biobased Applicator Tube Menstrual Tampon
HEB
Tampon, Menstrual, Unscented
175d
Cleared
Feb 09, 2018
iVitri Straw
MQK
Labware, Assisted Reproduction
150d
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
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