K061108 is an FDA 510(k) clearance for the STRYKER AUTO IRRIGATION SYSTEM. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Stryker (Kalamazoo, US). The FDA issued a Cleared decision on February 2, 2007, 288 days after receiving the submission on April 20, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K061108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2006 |
| Decision Date | February 02, 2007 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |