510(k) K820430

DIATHERMIC SNARES by American Endoscopy, Inc. — Product Code KNS

K820430 is an FDA 510(k) premarket notification submitted by American Endoscopy, Inc. for the device "DIATHERMIC SNARES". The FDA issued a decision of Substantially Equivalent on April 8, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1982
Date Received
February 17, 1982
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