K192873 is an FDA 510(k) clearance for the SX-One MicroKnife. This device is classified as a Orthopedic Manual Surgical Instrument (Class I - General Controls, product code LXH).
Submitted by Sonex Health, Inc. (Rochester, US). The FDA issued a Cleared decision on December 20, 2019, 73 days after receiving the submission on October 8, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K192873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2019 |
| Decision Date | December 20, 2019 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LXH - Orthopedic Manual Surgical Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |