510(k) K820240

PAPILLOTOMES by American Endoscopy, Inc. — Product Code KNS

K820240 is an FDA 510(k) premarket notification submitted by American Endoscopy, Inc. for the device "PAPILLOTOMES". The FDA issued a decision of Substantially Equivalent on March 26, 1982. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. American Endoscopy, Inc. has at least 10 other 510(k) clearances on record.