K132044 is an FDA 510(k) clearance for the CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM. This device is classified as a Cover, Burr Hole (Class II - Special Controls, product code GXR).
Submitted by Neos Surgery S.L (Alexandria, US). The FDA issued a Cleared decision on September 30, 2013, 90 days after receiving the submission on July 2, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5250.
| 510(k) Number | K132044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2013 |
| Decision Date | September 30, 2013 |
| Days to Decision | 90 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 |