K172907 is an FDA 510(k) clearance for the ELAN 4 Air Motor System. This device is classified as a Motor, Drill, Pneumatic (Class II - Special Controls, product code HBB).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 9, 2018, 410 days after receiving the submission on September 25, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4370.
| 510(k) Number | K172907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2017 |
| Decision Date | November 09, 2018 |
| Days to Decision | 410 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBB — Motor, Drill, Pneumatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4370 |