K153041 is an FDA 510(k) clearance for the Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on March 14, 2016, 147 days after receiving the submission on October 19, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K153041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2015 |
| Decision Date | March 14, 2016 |
| Days to Decision | 147 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 |