K152342 is an FDA 510(k) clearance for the Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover. This device is classified as a Cover, Burr Hole (Class II - Special Controls, product code GXR).
Submitted by St Jude Medical (Plano, US). The FDA issued a Cleared decision on June 9, 2016, 295 days after receiving the submission on August 19, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5250.
| 510(k) Number | K152342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2015 |
| Decision Date | June 09, 2016 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXR — Cover, Burr Hole |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5250 |