PROTOCOL Incision Dressing— 510(k) K142962

Substantially Equivalent

Deroyal Industries

FDA 510(k) clearance K142962 for PROTOCOL Incision Dressing, Substantially Equivalent on 2015-07-23. Applicant: Deroyal Industries.

Clearance details

Applicant: Deroyal Industries
Product code: Code FRO
Advisory panel: Unknown
Date received: 2014-10-14
Decision date: 2015-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.