K062406 is an FDA 510(k) clearance for the AESCULAP NEURO PATTIES. This device is classified as a Neurosurgical Paddie (Class II - Special Controls, product code HBA).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 15, 2006, 29 days after receiving the submission on August 17, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4700.
| 510(k) Number | K062406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2006 |
| Decision Date | September 15, 2006 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBA — Neurosurgical Paddie |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4700 |