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
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
Cleared
Dec 12, 2012
CRYOTOP
MQK
Labware, Assisted Reproduction
454d
Cleared
Dec 05, 2012
PKS BILL
HIN
Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
100d
Cleared
Nov 29, 2012
PLANER BT37 INCUBATOR
MQG
Accessory, Assisted Reproduction
184d
Cleared
Nov 26, 2012
KITAZATO OPU NEEDLE
MQE
Needle, Assisted Reproduction
458d
Cleared
Nov 20, 2012
RUMBLE TUFF
HGX
Pump, Breast, Powered
377d
Cleared
Nov 19, 2012
RESTORELLE L
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
101d
Cleared
Nov 15, 2012
FEMMYCYCLE
HHE
Cup, Menstrual
142d
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