510(k) K781353

PAPILLOTOME CUTTING SNARE by Cameron-Miller, Inc. — Product Code KNS

K781353 is an FDA 510(k) premarket notification submitted by Cameron-Miller, Inc. for the device "PAPILLOTOME CUTTING SNARE". The FDA issued a decision of Substantially Equivalent on October 10, 1978. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Cameron-Miller, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
August 7, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type