BRAIDED POLYESTER SURGICAL SUTURE— 510(k) K930945

Substantially Equivalent

Lukens Medical Corp.

FDA 510(k) clearance K930945 for BRAIDED POLYESTER SURGICAL SUTURE, Substantially Equivalent on 1993-12-17. Applicant: Lukens Medical Corp..

Clearance details

Applicant: Lukens Medical Corp.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 1993-02-23
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

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Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.