K241883 is an FDA 510(k) clearance for the DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00). This device is classified as a Holder, Head, Neurosurgical (skull Clamp) (Class II - Special Controls, product code HBL).
Submitted by Pro-Med Instruments GmbH (Freiburg, DE). The FDA issued a Cleared decision on July 26, 2024, 28 days after receiving the submission on June 28, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4460.
| 510(k) Number | K241883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2024 |
| Decision Date | July 26, 2024 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBL - Holder, Head, Neurosurgical (skull Clamp) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4460 |