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
3155 Obstetrics & Gynecology devices
Cleared
Apr 06, 2006
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
216d
Cleared
Apr 04, 2006
DICK'S FORMALWEAR MALE LATEX CONDOM
HIS
Condom
357d
Cleared
Mar 31, 2006
OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
HIH
Hysteroscope (and Accessories)
98d
Cleared
Mar 23, 2006
OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
MQL
Media, Reproductive
98d
Cleared
Mar 23, 2006
DOPPLEX CENTRALE
HGM
System, Monitoring, Perinatal
52d
Cleared
Feb 28, 2006
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
MOL
Condom, Synthetic
333d
Cleared
Feb 21, 2006
MALE NATURAL RUBBER LATEX CONDOM
HIS
Condom
78d
Cleared
Feb 17, 2006
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
HGM
System, Monitoring, Perinatal
287d
Cleared
Feb 17, 2006
K-Y BRAND SENSUAL MIST
NUC
Lubricant, Personal
73d
Cleared
Feb 15, 2006
I-D GLIDE
NUC
Lubricant, Personal
273d
Cleared
Feb 08, 2006
CARBONAID GAS DIFFUSER
HIF
Insufflator, Laparoscopic
187d
Cleared
Feb 06, 2006
SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT
NUC
Lubricant, Personal
181d
Cleared
Feb 06, 2006
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
66d
Cleared
Feb 03, 2006
VIELLE LUBRICANT
HIS
Condom
261d
Cleared
Feb 02, 2006
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
HIB
Speculum, Vaginal, Nonmetal
175d
Cleared
Jan 30, 2006
CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007
MQF
Catheter, Assisted Reproduction
75d
Cleared
Jan 27, 2006
DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
HIS
Condom
98d
Cleared
Dec 30, 2005
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
HGM
System, Monitoring, Perinatal
88d
Cleared
Dec 27, 2005
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
HEB
Tampon, Menstrual, Unscented
223d
Cleared
Dec 27, 2005
MENTOR NOVASILK MESH
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
20d
Cleared
Dec 22, 2005
CALM CURVE, VERSION 01.00
HGM
System, Monitoring, Perinatal
84d
Cleared
Dec 21, 2005
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
HHK
Curette, Suction, Endometrial (and Accessories)
217d
Cleared
Dec 16, 2005
FC 700 FETAL MONITOR
HGM
System, Monitoring, Perinatal
352d
Cleared
Dec 16, 2005
FC 1400 FETAL MONITOR
HGM
System, Monitoring, Perinatal
352d
Cleared
Dec 16, 2005
WARMING LIQUID PERSONAL LUBRICANT
NUC
Lubricant, Personal
53d
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