K014091 is an FDA 510(k) clearance for the STRYKER PAINPUMP. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on December 31, 2001, 19 days after receiving the submission on December 12, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K014091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2001 |
| Decision Date | December 31, 2001 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |