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
Jun 10, 2005
XENFORM SOFT TISSUE REPAIR MATRIX
PAJ
Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
31d
Cleared
Jun 08, 2005
ENHANCE CLITORAL STIMULATION AID
NBV
Device, Engorgement, Clitoral
174d
Cleared
May 12, 2005
FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
58d
Cleared
May 02, 2005
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
MQF
Catheter, Assisted Reproduction
62d
Cleared
Apr 28, 2005
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
MRX
System, Assisted Reproduction Laser
34d
Cleared
Apr 21, 2005
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
HDB
Extractor, Vacuum, Fetal
311d
Cleared
Apr 21, 2005
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
HET
Laparoscope, Gynecologic (and Accessories)
63d
Cleared
Apr 14, 2005
CUMULASE
MQL
Media, Reproductive
212d
Cleared
Apr 14, 2005
VACULINK, MODEL VCL 3000
HDB
Extractor, Vacuum, Fetal
105d
Cleared
Apr 08, 2005
DUREX PLAY TINGLING LUBRICANT
NUC
Lubricant, Personal
163d
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 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 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 13, 2005
SAN-MAR LABS LUBRICATING JELLY
HIS
Condom
209d
Cleared
Jan 13, 2005
POWERSTICK MALE LATEX CONDOMS
HIS
Condom
203d
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