510(k) K191048

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

K191048 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "AcuSnare Polypectomy Snare - Duckbill". The FDA issued a decision of Substantially Equivalent on July 18, 2019. 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
July 18, 2019
Date Received
April 19, 2019
Clearance Type
Special
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