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
Apr 08, 2005
MALE NATURAL RUBBER LATEX CONDOM
HIS
Condom
65d
Cleared
Apr 05, 2005
DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
HIS
Condom
204d
Cleared
Apr 01, 2005
SURGICAL DESIGN CIRCUMCISION CLAMP
HFX
Clamp, Circumcision
100d
Cleared
Mar 31, 2005
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
GCJ
Laparoscope, General & Plastic Surgery
17d
Cleared
Mar 30, 2005
MOONCUP, STYLE A & B
HHE
Cup, Menstrual
413d
Cleared
Mar 17, 2005
PERSONAL WARMING GEL
NUC
Lubricant, Personal
45d
Cleared
Mar 17, 2005
PERSONAL WARMING JELLY
NUC
Lubricant, Personal
45d
Cleared
Mar 09, 2005
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150
PAI
Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
23d
Cleared
Mar 04, 2005
MILTEX LAPAROSCOPIC INSTRUMENTS
HET
Laparoscope, Gynecologic (and Accessories)
122d
Cleared
Mar 01, 2005
TULIP CONDOM
HIS
Condom
15d
Cleared
Feb 17, 2005
DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
HIS
Condom
113d
Cleared
Feb 08, 2005
CALM PATTERNS, VERSION 01.00.00
HGM
System, Monitoring, Perinatal
316d
Cleared
Feb 02, 2005
CERVEX-BRUSH COMBI
HHT
Spatula, Cervical, Cytological
56d
Cleared
Feb 01, 2005
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
20d
Cleared
Jan 21, 2005
AIRSTRIP OB
HGM
System, Monitoring, Perinatal
171d
Cleared
Jan 18, 2005
ATAD ARD CATHETER
HDY
Dilator, Cervical, Hygroscopic-laminaria
315d
Cleared
Jan 13, 2005
SAN-MAR LABS LUBRICATING JELLY
HIS
Condom
209d
Cleared
Jan 13, 2005
POWERSTICK MALE LATEX CONDOMS
HIS
Condom
203d
Cleared
Jan 13, 2005
ICSI-100
MQL
Media, Reproductive
64d
Cleared
Dec 23, 2004
FEMSPEC DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
177d
Cleared
Dec 22, 2004
GYNECARE PROLENE FASTENER SYSTEM
PBQ
Fixation, Non-absorbable Or Absorbable, For Pelvic Use
89d
Cleared
Dec 15, 2004
GERBER DOUBLE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
36d
Cleared
Nov 30, 2004
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
HIS
Condom
186d
Cleared
Nov 30, 2004
VAG O SPECULUM, MODELS VS1, VM1, VL1
HIB
Speculum, Vaginal, Nonmetal
35d
Cleared
Nov 23, 2004
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
49d
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