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
Nov 13, 2012
HIGH FLOW INSUFFLANTION UNIT
HIF
Insufflator, Laparoscopic
113d
Cleared
Nov 05, 2012
THE ABLATION SYSTEM
HFG
Coagulator, Laparoscopic, Unipolar (and Accessories)
132d
Cleared
Nov 02, 2012
IUI CATHETERS
MQF
Catheter, Assisted Reproduction
441d
Cleared
Nov 02, 2012
LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
HIS
Condom
253d
Cleared
Oct 26, 2012
SPERMFREEZE SOLUTION
MQL
Media, Reproductive
309d
Cleared
Oct 18, 2012
DOMAIN SURGICAL SYSTEM
HGI
Electrocautery, Gynecologic (and Accessories)
114d
Cleared
Oct 16, 2012
ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
NUC
Lubricant, Personal
441d
Cleared
Oct 16, 2012
AMS LARGE PORE POLYPROPHLENE MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
119d
Cleared
Oct 12, 2012
ANCHORSURE
PBQ
Fixation, Non-absorbable Or Absorbable, For Pelvic Use
207d
Cleared
Oct 09, 2012
CERNER FETALINK+(VERSION1.0)
HGM
System, Monitoring, Perinatal
116d
Cleared
Oct 04, 2012
NIRVANA A PERSONAL LUBRICANT
NUC
Lubricant, Personal
210d
Cleared
Oct 03, 2012
NIRVANA B PERSONAL LUBRICANT
NUC
Lubricant, Personal
205d
Cleared
Sep 26, 2012
EMBRYOGEN
MQL
Media, Reproductive
253d
Cleared
Sep 19, 2012
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
HGM
System, Monitoring, Perinatal
260d
Cleared
Sep 19, 2012
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
HIH
Hysteroscope (and Accessories)
28d
Cleared
Sep 18, 2012
SCKOONCUP
HHE
Cup, Menstrual
249d
Cleared
Sep 10, 2012
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
HIH
Hysteroscope (and Accessories)
25d
Cleared
Sep 06, 2012
FOCUS TOUCH CONCEPTION SYSTEM
OBB
Kit, Conception-assist, Home Use
402d
Cleared
Aug 17, 2012
NEBULAE I
HIF
Insufflator, Laparoscopic
212d
Cleared
Aug 03, 2012
SHANGRING
HFX
Clamp, Circumcision
45d
Cleared
Jul 20, 2012
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
49d
Cleared
Jul 19, 2012
CONTINUOUS SINGLE CULTURE COMPLETE
MQL
Media, Reproductive
51d
Cleared
Jul 19, 2012
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
HIH
Hysteroscope (and Accessories)
23d
Cleared
Jul 18, 2012
INSUFLOW SYNERGY PORT
HIF
Insufflator, Laparoscopic
138d
Cleared
Jul 13, 2012
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
HEW
Culdoscope (and Accessories)
459d
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