510(k) K171993

Zimmon Needle Knife Papillotome by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code KNS

K171993 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical Inc./Cook Endoscopy for the device "Zimmon Needle Knife Papillotome". The FDA issued a decision of Substantially Equivalent on August 17, 2017. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Wilson-Cook Medical Inc./Cook Endoscopy has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2017
Date Received
July 3, 2017
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