510(k) K974018

WILSON-COOK 10 SHOT MULTI-BAND LIGATOR by Wilson-Cook Medical, Inc. — Product Code FHN

K974018 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "WILSON-COOK 10 SHOT MULTI-BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on January 20, 1998. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1998
Date Received
October 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Hemorrhoidal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type