JENNINGS JAVELIN— 510(k) K942548

Substantially Equivalent

Jfi Endineering, Inc.

FDA 510(k) clearance K942548 for JENNINGS JAVELIN, Substantially Equivalent on 1994-11-03. Applicant: Jfi Endineering, Inc..

Clearance details

Applicant: Jfi Endineering, Inc.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 1994-05-31
Decision date: 1994-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.