K193630 is an FDA 510(k) clearance for the hekaDrill. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by Zethon, Ltd. (Aston Clinton, GB). The FDA issued a Cleared decision on April 9, 2021, 470 days after receiving the submission on December 26, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K193630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2019 |
| Decision Date | April 09, 2021 |
| Days to Decision | 470 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBC - Motor, Drill, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4360 |