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 16, 2001
MN-4 COARSE MANIPULATOR
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
44d
Cleared
Mar 15, 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
30d
Cleared
Mar 09, 2001
SONICAID FM820, SONICAID FM830
HGM
System, Monitoring, Perinatal
235d
Cleared
Mar 09, 2001
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
NUC
Lubricant, Personal
87d
Cleared
Mar 09, 2001
VCF PERSONAL LUBRICANT
NUC
Lubricant, Personal
49d
Cleared
Mar 06, 2001
FETAL ASSIST
HGM
System, Monitoring, Perinatal
201d
Cleared
Mar 05, 2001
MULTI CARE THERAPEUTIC VIBRATOR
KXQ
Vibrator For Therapeutic Use, Genital
53d
Cleared
Mar 02, 2001
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
HIF
Insufflator, Laparoscopic
407d
Cleared
Feb 22, 2001
TAUT-INSUFFLATION NEEDLE
HIF
Insufflator, Laparoscopic
83d
Cleared
Feb 21, 2001
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
HIB
Speculum, Vaginal, Nonmetal
156d
Cleared
Feb 21, 2001
STRYKER HEATED INSUFFLATOR TUBE SET
HIF
Insufflator, Laparoscopic
75d
Cleared
Feb 20, 2001
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
HGI
Electrocautery, Gynecologic (and Accessories)
90d
Cleared
Feb 09, 2001
(DISPOSABLE) VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
85d
Cleared
Feb 08, 2001
ENVIVE MINIFORMS
HHD
Pad, Menstrual, Unscented
58d
Cleared
Feb 01, 2001
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
HGI
Electrocautery, Gynecologic (and Accessories)
211d
Cleared
Feb 01, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
LKF
Cannula, Manipulator/injector, Uterine
24d
Cleared
Jan 29, 2001
BIOTEQUE VAGINAL DILATOR
HDX
Dilator, Vaginal
90d
Cleared
Jan 28, 2001
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
LTZ
Condom With Nonoxynol-9
90d
Cleared
Jan 17, 2001
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
MQL
Media, Reproductive
90d
Cleared
Jan 17, 2001
HYALURONIDASE REAGENT, MODEL CAT#2212
MQL
Media, Reproductive
43d
Cleared
Jan 08, 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
HET
Laparoscope, Gynecologic (and Accessories)
90d
Cleared
Dec 28, 2000
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
NBV
Device, Engorgement, Clitoral
220d
Cleared
Dec 21, 2000
SERUM PROTEIN SUBSTITUTE
MQL
Media, Reproductive
17d
Cleared
Dec 19, 2000
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
HIS
Condom
134d
Cleared
Dec 15, 2000
MTG - MINITUB HEATED STAGE SYSTEMS
MQG
Accessory, Assisted Reproduction
84d
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