K050044 is an FDA 510(k) clearance for the MEDTRONIC CLIP GUN KIT. This device is classified as a Clip, Scalp (Class II - Special Controls, product code HBO).
Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on February 7, 2005, 28 days after receiving the submission on January 10, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4150.
| 510(k) Number | K050044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2005 |
| Decision Date | February 07, 2005 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBO — Clip, Scalp |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4150 |