HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240— 510(k) K993157

Substantially Equivalent

Weck Closure Systems

FDA 510(k) clearance K993157 for HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240, Substantially Equivalent on 1999-12-17. Applicant: Weck Closure Systems.

Clearance details

Applicant: Weck Closure Systems
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 1999-09-21
Decision date: 1999-12-17
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.