IMPACT MODEL 308— 510(k) K841538

Substantially Equivalent

Impact Instrumentation, Inc.

FDA 510(k) clearance K841538 for IMPACT MODEL 308, Substantially Equivalent on 1984-06-11. Applicant: Impact Instrumentation, Inc..

Clearance details

Applicant: Impact Instrumentation, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 1984-04-16
Decision date: 1984-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.