HEM-O-LOK MODEL NUMBERS 523900, 523970— 510(k) K982941

Substantially Equivalent

Weck Closure Systems

FDA 510(k) clearance K982941 for HEM-O-LOK MODEL NUMBERS 523900, 523970, Substantially Equivalent on 1998-11-19. Applicant: Weck Closure Systems.

Clearance details

Applicant: Weck Closure Systems
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 1998-08-21
Decision date: 1998-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

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Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.