FGC — Urethroscope Class II

FDA Device Classification

FDA product code FGC covers "Urethroscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FGC
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K091600percuvisionDIRECTVISION GUIDE SYSTEMAugust 25, 2009
K945907karl storz endoscopy-americaKARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC EMay 12, 1995
K800913kliGYNECOLOGICAL CYSTO/URETHROSCOPEMay 14, 1980