510(k) K911700

MONOPOLAR POLLYPECTOMY SNARE by Everest Medical Corp. — Product Code KNS

K911700 is an FDA 510(k) premarket notification submitted by Everest Medical Corp. for the device "MONOPOLAR POLLYPECTOMY SNARE". The FDA issued a decision of Substantially Equivalent on July 1, 1991. 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
July 1, 1991
Date Received
April 16, 1991
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