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
3153 Obstetrics & Gynecology devices
Cleared
Jul 17, 2007
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
HGX
Pump, Breast, Powered
152d
Cleared
Jul 03, 2007
LG SPERM FREEZING
MQL
Media, Reproductive
112d
Cleared
May 30, 2007
ARAGON SURGICAL LAPCAP
HIF
Insufflator, Laparoscopic
82d
Cleared
May 23, 2007
45L CORE INSUFFLATOR, MODEL F114
HIF
Insufflator, Laparoscopic
197d
Cleared
May 23, 2007
SALINE/ CONTRAST MEDIA INFUSION CATHETER
LKF
Cannula, Manipulator/injector, Uterine
171d
Cleared
May 18, 2007
FEMTEN CERVICAL TENACULUM
HDC
Tenaculum, Uterine
260d
Cleared
May 18, 2007
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
MQK
Labware, Assisted Reproduction
134d
Cleared
May 18, 2007
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
HIB
Speculum, Vaginal, Nonmetal
43d
Cleared
May 08, 2007
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
HIS
Condom
43d
Cleared
Apr 24, 2007
ZILOS-TK
MRX
System, Assisted Reproduction Laser
138d
Cleared
Apr 13, 2007
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
25d
Cleared
Apr 04, 2007
CVS PERSONAL LUBRICANT AND MOISTURIZER
NUC
Lubricant, Personal
208d
Cleared
Mar 26, 2007
BANANA RIBBED
HIS
Condom
137d
Cleared
Mar 23, 2007
K-Y BRAND WARMING LIQUID
NUC
Lubricant, Personal
25d
Cleared
Mar 16, 2007
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
HHT
Spatula, Cervical, Cytological
207d
Cleared
Mar 14, 2007
CONCEIVEX CONCEPTION KIT
OBB
Kit, Conception-assist, Home Use
141d
Cleared
Mar 12, 2007
SATURN 3 LASER SYSTEM
MRX
System, Assisted Reproduction Laser
356d
Cleared
Mar 12, 2007
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
88d
Cleared
Feb 26, 2007
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
91d
Cleared
Feb 08, 2007
EMBRYOASSIST
MQL
Media, Reproductive
274d
Not Cleared
Jan 30, 2007
COMPUTERIZED LABOR MONITORING SYSTEM
NPB
System, Monitoring, For Progress Of Labor
104d
Cleared
Jan 26, 2007
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
NUC
Lubricant, Personal
150d
Cleared
Jan 17, 2007
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
HFX
Clamp, Circumcision
65d
Cleared
Jan 10, 2007
INSUFLOW DEVICE, MODEL 6198
HIF
Insufflator, Laparoscopic
47d
Cleared
Dec 26, 2006
MOONCUP
HHE
Cup, Menstrual
273d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices