K080875 is an FDA 510(k) clearance for the PIGALILEO 4TH GENERATION SYSTEM. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 18, 2008, 109 days after receiving the submission on March 31, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K080875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2008 |
| Decision Date | July 18, 2008 |
| Days to Decision | 109 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |