510(k) K895900

WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE by Wilson-Cook Medical, Inc. — Product Code FCK

K895900 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE". The FDA issued a decision of Substantially Equivalent on January 11, 1990. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
October 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy, Suction
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type