510(k) K800965

M.R. ASSOC. SNARES; CRESCENT SNARE WIRE by Mr Associates, Inc. — Product Code KNS

K800965 is an FDA 510(k) premarket notification submitted by Mr Associates, Inc. for the device "M.R. ASSOC. SNARES; CRESCENT SNARE WIRE". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Mr Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 23, 1980
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