GCF — Proctoscope Class II

FDA Device Classification

FDA product code GCF covers "Proctoscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GCF
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
K945209karl storz endoscopy-americaPROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTSMarch 6, 1995
K790856c. intlPROCTOSCOPE #501May 29, 1979