K033340 is an FDA 510(k) clearance for the LEKSELL SURGIPLAN WITH IMAGEMERGE. 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 February 12, 2004, 118 days after receiving the submission on October 17, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K033340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2003 |
| Decision Date | February 12, 2004 |
| Days to Decision | 118 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 |