SAFE-T-STIK— 510(k) K904382

Substantially Equivalent

Xikon Technology

FDA 510(k) clearance K904382 for SAFE-T-STIK, Substantially Equivalent on 1990-10-17. Applicant: Xikon Technology.

Clearance details

Applicant: Xikon Technology
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1990-09-26
Decision date: 1990-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.