K152558 is an FDA 510(k) clearance for the Leksell Stereotactic System, Injection/ Aspiration Needle Kit. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on March 2, 2016, 175 days after receiving the submission on September 9, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K152558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2015 |
| Decision Date | March 02, 2016 |
| Days to Decision | 175 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HAW - Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |