510(k) K870705

THERMAL COAGULATOR by Microvasive — Product Code KNS

K870705 is an FDA 510(k) premarket notification submitted by Microvasive for the device "THERMAL COAGULATOR". The FDA issued a decision of Substantially Equivalent on April 17, 1987. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Microvasive has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1987
Date Received
February 20, 1987
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