K213697 is an FDA 510(k) clearance for the ORiGO System. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by Bien-Air Surgery SA (Le Noirmont, CH). The FDA issued a Cleared decision on October 31, 2022, 342 days after receiving the submission on November 23, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K213697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2021 |
| Decision Date | October 31, 2022 |
| Days to Decision | 342 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 |