DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE— 510(k) K821024

Name: FDA 510(k) clearance K821024
Creator: U.S. Food and Drug Administration
Published: 1982-05-14

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K821024 for DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE, Substantially Equivalent on 1982-05-14. Applicant: Howmedica Corp.. Device class: 1.

Clearance details

Applicant: Howmedica Corp.
Product code: Code GDT
Device class: Class 1
Regulation: 21 CFR 878.4760
Advisory panel: General, Plastic Surgery
Date received: 1982-04-13
Decision date: 1982-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDT

product code GDT

Malfunction: 752
Total: 752

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.