510(k) K173673

AcuSnare Polypectomy Snare by Wilson-Cook Medical, Inc. — Product Code FDI

K173673 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "AcuSnare Polypectomy Snare". The FDA issued a decision of Substantially Equivalent on August 24, 2018. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2018
Date Received
November 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type