Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2— 510(k) K150327

Substantially Equivalent

Dunamis, LLC

FDA 510(k) clearance K150327 for Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2, Substantially Equivalent on 2015-06-29. Applicant: Dunamis, LLC.

Clearance details

Applicant: Dunamis, LLC
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2015-02-10
Decision date: 2015-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, AL, 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.