ADFUSE(TM)— 510(k) K881590

Substantially Equivalent

Healthtek, Inc.

FDA 510(k) clearance K881590 for ADFUSE(TM), Substantially Equivalent on 1988-05-23. Applicant: Healthtek, Inc..

Clearance details

Applicant: Healthtek, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1988-04-13
Decision date: 1988-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.