K152152 is an FDA 510(k) clearance for the Codman Certas Plus Programmable Valve. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on October 27, 2015, 85 days after receiving the submission on August 3, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K152152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2015 |
| Decision Date | October 27, 2015 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| 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 |