K213228 is an FDA 510(k) clearance for the NeuroLine Disposable Cranial Perforator with Hudson end. This device is classified as a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II - Special Controls, product code HBF).
Submitted by Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. (Debrecen, HU). The FDA issued a Cleared decision on June 20, 2022, 264 days after receiving the submission on September 29, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4305.
| 510(k) Number | K213228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | June 20, 2022 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBF - Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4305 |