K150801 is an FDA 510(k) clearance for the Stryker Maestro Air Motors. This device is classified as a Motor, Drill, Pneumatic (Class II - Special Controls, product code HBB).
Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on May 22, 2015, 57 days after receiving the submission on March 26, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4370.
| 510(k) Number | K150801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2015 |
| Decision Date | May 22, 2015 |
| Days to Decision | 57 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBB — Motor, Drill, Pneumatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4370 |