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
3151 Obstetrics & Gynecology devices
Cleared
Apr 25, 2013
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
209d
Cleared
Apr 09, 2013
WARMING JELLY PERSONAL LUBRICANT
NUC
Lubricant, Personal
123d
Cleared
Apr 05, 2013
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
322d
Cleared
Apr 05, 2013
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
PAI
Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
93d
Cleared
Apr 04, 2013
HYSTEROSCOPY PUMP HM6
HIG
Insufflator, Hysteroscopic
120d
Cleared
Mar 21, 2013
SUNRAY FETAL MONITOR
HGM
System, Monitoring, Perinatal
146d
Cleared
Mar 21, 2013
VEEDA 100% COTTON MENSTRUAL TAMPON
HEB
Tampon, Menstrual, Unscented
14d
Cleared
Mar 19, 2013
IOGYN ENDOSCOPE
HIH
Hysteroscope (and Accessories)
144d
Cleared
Mar 08, 2013
ENDOSEE MODEL 8000 U-SCOPE
HIH
Hysteroscope (and Accessories)
150d
Cleared
Mar 07, 2013
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
NUC
Lubricant, Personal
205d
Cleared
Mar 05, 2013
RESTORELLE Y CONTOUR
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
76d
Cleared
Mar 01, 2013
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
HET
Laparoscope, Gynecologic (and Accessories)
121d
Cleared
Feb 22, 2013
LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
NUC
Lubricant, Personal
170d
Cleared
Feb 21, 2013
VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
113d
Cleared
Feb 19, 2013
LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
NUC
Lubricant, Personal
189d
Cleared
Feb 14, 2013
MALE LATEX CONDOM
HIS
Condom
295d
Cleared
Feb 14, 2013
LIFESTYLES NATURAL PERSONAL LUBRICANT
NUC
Lubricant, Personal
216d
Cleared
Jan 31, 2013
THE ADVANCE CATHETER FOR HSG AND SIS
LKF
Cannula, Manipulator/injector, Uterine
105d
Cleared
Dec 28, 2012
LANSINOH POWERED ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
136d
Cleared
Dec 20, 2012
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
PCF
Sampler, Endocervical
111d
Cleared
Dec 19, 2012
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
MQK
Labware, Assisted Reproduction
464d
Cleared
Dec 19, 2012
ONTEX AND OTHER PROPRIETARY NAMES
HEB
Tampon, Menstrual, Unscented
114d
Cleared
Dec 18, 2012
UPSYLON Y MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
97d
Cleared
Dec 18, 2012
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
84d
Cleared
Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
122d
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