510(k) K920089

MONOPOLAR COAGULATING POLYPECTOMY SNARE by Everest Medical Corp. — Product Code KNS

K920089 is an FDA 510(k) premarket notification submitted by Everest Medical Corp. for the device "MONOPOLAR COAGULATING POLYPECTOMY SNARE". The FDA issued a decision of Substantially Equivalent on March 31, 1992. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Everest Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1992
Date Received
January 8, 1992
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