Dunamis Force DFX Tensile Tape— 510(k) K153746

Substantially Equivalent

Dunamis, LLC

FDA 510(k) clearance K153746 for Dunamis Force DFX Tensile Tape, Substantially Equivalent on 2016-03-03. Applicant: Dunamis, LLC.

Clearance details

Applicant: Dunamis, LLC
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2015-12-29
Decision date: 2016-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, AL, US

Download summary PDF View on FDA.gov ↗

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.