510(k) K833492

PERCUTANEOUS ENDOSCOPIC GASTROSCOPY by American Endoscopy, Inc. — Product Code KNT

K833492 is an FDA 510(k) premarket notification submitted by American Endoscopy, Inc. for the device "PERCUTANEOUS ENDOSCOPIC GASTROSCOPY". The FDA issued a decision of Substantially Equivalent on November 29, 1983. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. American Endoscopy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1983
Date Received
October 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type