Submission Details
| 510(k) Number | K043466 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 2004 |
| Decision Date | May 10, 2005 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
PAINPUMP2
May 2005
Decision
146d
Days
Class 2
Risk
About This 510(k) Submission
K043466 is an FDA 510(k) clearance for the PAINPUMP2, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on May 10, 2005, 146 days after receiving the submission on December 15, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.
Device Classification
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
Manufacturer
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