K160811 is an FDA 510(k) clearance for the CRW STEREOTACTIC SYSTEM. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 6, 2016, 257 days after receiving the submission on March 24, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K160811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2016 |
| Decision Date | December 06, 2016 |
| Days to Decision | 257 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |