STROVER HOOK— 510(k) K841617

Name: FDA 510(k) clearance K841617
Creator: U.S. Food and Drug Administration
Published: 1984-08-27

Substantially Equivalent

Plastafil, Inc.

FDA 510(k) clearance K841617 for STROVER HOOK, Substantially Equivalent on 1984-08-27. Applicant: Plastafil, Inc.. Device class: 1.

Clearance details

Applicant: Plastafil, Inc.
Product code: Code HCF
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-04-19
Decision date: 1984-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HCF

product code HCF

Death: 6
Other: 1
Total: 7

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.