SCALPEL HANDLE— 510(k) K854858

Substantially Equivalent

Medelec Intl. Corp.

FDA 510(k) clearance K854858 for SCALPEL HANDLE, Substantially Equivalent on 1985-12-24. Applicant: Medelec Intl. Corp..

Clearance details

Applicant: Medelec Intl. Corp.
Product code: Code GDZ
Advisory panel: General, Plastic Surgery
Date received: 1985-12-05
Decision date: 1985-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

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Adverse events under product code GDZ

product code GDZ

Other: 1
Total: 1

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.