K053127 is an FDA 510(k) clearance for the IPLAN. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on February 9, 2006, 94 days after receiving the submission on November 7, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K053127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2005 |
| Decision Date | February 09, 2006 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| 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 |