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 10, 2008
DUREX PLAY MASSAGE GEL LUBRICANT
NUC
Lubricant, Personal
488d
Cleared
Mar 06, 2008
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
MOL
Condom, Synthetic
349d
Cleared
Mar 06, 2008
K-Y BRAND YOURS+MINE
NUC
Lubricant, Personal
191d
Cleared
Mar 05, 2008
ALICIA MENSTRUAL CUP
HHE
Cup, Menstrual
335d
Cleared
Feb 12, 2008
SINGLE STEP MEDIUM
MQL
Media, Reproductive
148d
Cleared
Feb 08, 2008
MEDLINE DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
114d
Cleared
Jan 31, 2008
CERVICAL MD, MODEL C10
HEX
Colposcope (and Colpomicroscope)
129d
Cleared
Jan 30, 2008
SOFTPAP CERVICAL CELL COLLECTOR
HHT
Spatula, Cervical, Cytological
159d
Cleared
Jan 30, 2008
LYOPHILIZED MULTIBLAST MEDIUM KIT
MQL
Media, Reproductive
135d
Cleared
Jan 25, 2008
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
MQL
Media, Reproductive
130d
Cleared
Jan 25, 2008
GLYCERIN & PARABEN FREE ASTROGLIDE
NUC
Lubricant, Personal
128d
Cleared
Jan 25, 2008
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
HIF
Insufflator, Laparoscopic
120d
Cleared
Jan 23, 2008
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
HDW
Diaphragm, Contraceptive (and Accessories)
456d
Cleared
Jan 22, 2008
DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
HIB
Speculum, Vaginal, Nonmetal
116d
Cleared
Jan 17, 2008
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
22d
Cleared
Jan 14, 2008
RICHTER MALE LATEX CONDOM
HIS
Condom
326d
Cleared
Jan 11, 2008
MODIFICATION TO: ARAGON SURGICAL LAPCAP
HIF
Insufflator, Laparoscopic
32d
Cleared
Dec 20, 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
HGM
System, Monitoring, Perinatal
56d
Cleared
Dec 19, 2007
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
62d
Cleared
Dec 13, 2007
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
HIF
Insufflator, Laparoscopic
267d
Cleared
Dec 12, 2007
K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
NUC
Lubricant, Personal
112d
Cleared
Dec 12, 2007
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
110d
Cleared
Nov 28, 2007
GYN DISPOSABLES TENACULUM 356T
HDC
Tenaculum, Uterine
15d
Cleared
Nov 16, 2007
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
HIH
Hysteroscope (and Accessories)
207d
Cleared
Nov 15, 2007
UNIDUS MAGNUM MALE LATEX CONDOM
HIS
Condom
49d
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