510(k) K103726

JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS by Integra LifeSciences Corporation — Product Code KNF

K103726 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on February 8, 2012. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2012
Date Received
December 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type