510(k) K042454

STRYKER CASSETTE PUMP by Stryker Endoscopy — Product Code GCX

K042454 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "STRYKER CASSETTE PUMP". The FDA issued a decision of Substantially Equivalent on December 9, 2004. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Stryker Endoscopy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2004
Date Received
September 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type