GCO — Endoscope, Mirror Class II

FDA Device Classification

FDA product code GCO covers "Endoscope, Mirror", 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
GCO
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
K862838cytotechCYTOTECH HSV IGG ENZYME IMMUNOASSAYDecember 9, 1986
K862717simpson/basyeHAND MIRROR (ENDOSCOPE)July 30, 1986
K790340johnson and johnson professionalsDELTA-ROLApril 12, 1979