Cleared Traditional

STRYKER CASSETTE PUMP

K042454 · Stryker Endoscopy · General Hospital
Dec 2004
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K042454 is an FDA 510(k) clearance for the STRYKER CASSETTE PUMP, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on December 9, 2004, 90 days after receiving the submission on September 10, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K042454 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2004
Decision Date December 09, 2004
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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