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
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
Cleared
Dec 15, 2005
YUSHENG DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
59d
Cleared
Dec 12, 2005
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
147d
Cleared
Nov 22, 2005
IUI CATHETER, MODEL 9057
MQF
Catheter, Assisted Reproduction
116d
Cleared
Nov 09, 2005
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
HIB
Speculum, Vaginal, Nonmetal
76d
Cleared
Nov 01, 2005
EVENFLO ELAN BREAST PUMP
HGX
Pump, Breast, Powered
15d
Cleared
Oct 17, 2005
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
HEE
Set, Anesthesia, Paracervical
49d
Cleared
Oct 07, 2005
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
MQE
Needle, Assisted Reproduction
101d
Cleared
Oct 04, 2005
FETAL MONITOR, MODELS BT-300 AND BT-200
HGM
System, Monitoring, Perinatal
54d
Cleared
Sep 22, 2005
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
HGX
Pump, Breast, Powered
55d
Cleared
Sep 08, 2005
ZIVF-AIRE
MQG
Accessory, Assisted Reproduction
415d
Cleared
Sep 07, 2005
WHITTLESTONE EXPRESSER
HGX
Pump, Breast, Powered
128d
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