K113526 is an FDA 510(k) clearance for the CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Medos International SARL (Raynham, US). The FDA issued a Cleared decision on February 16, 2012, 78 days after receiving the submission on November 30, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K113526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2011 |
| Decision Date | February 16, 2012 |
| Days to Decision | 78 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXG — Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |