K004027 is an FDA 510(k) clearance for the STRYKER REMOTE SURGICAL PLANNING SYSTEM. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on January 24, 2001, 28 days after receiving the submission on December 27, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K004027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2000 |
| Decision Date | January 24, 2001 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |