K042454 is an FDA 510(k) clearance for the STRYKER CASSETTE PUMP. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K042454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |