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
3153 Obstetrics & Gynecology devices
Cleared
May 28, 2008
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
HGM
System, Monitoring, Perinatal
30d
Cleared
May 19, 2008
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
MQH
Microtools, Assisted Reproduction (pipettes)
248d
Cleared
May 15, 2008
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
346d
Cleared
May 07, 2008
DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
NUC
Lubricant, Personal
271d
Cleared
May 02, 2008
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
GEI
Electrosurgical, Cutting & Coagulation & Accessories
109d
Cleared
Apr 17, 2008
INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
HIH
Hysteroscope (and Accessories)
111d
Cleared
Apr 10, 2008
ELEGANCE WOMAN'S LUBRICANT
NUC
Lubricant, Personal
406d
Cleared
Apr 10, 2008
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
76d
Cleared
Apr 01, 2008
DUREX PLAY SOFT & SENSUAL LUBRICANT
NUC
Lubricant, Personal
292d
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
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