K203739 is an FDA 510(k) clearance for the ELAN 4 Electro Motor System. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on August 24, 2021, 245 days after receiving the submission on December 22, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K203739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2020 |
| Decision Date | August 24, 2021 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBE — Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |