510(k) K944220

WILSON COOK MULTIPLE BAND LIGATOR by Wilson-Cook Medical, Inc. — Product Code MND

K944220 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "WILSON COOK MULTIPLE BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on January 24, 1995. The device falls under product code MND (Ligator, Esophageal), 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 24, 1995
Date Received
August 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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