SX-One MicroKnife— 510(k) K192873

Substantially Equivalent

Sonex Health, Inc.

FDA 510(k) clearance K192873 for SX-One MicroKnife, Substantially Equivalent on 2019-12-20. Applicant: Sonex Health, Inc..

Clearance details

Applicant: Sonex Health, Inc.
Product code: Code LXH
Advisory panel: Orthopedic
Date received: 2019-10-08
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.