MTR550 (Tentative) Antimicrobial Silver Wound Gel— 510(k) K152519

Substantially Equivalent

Medical Technology Research, Inc.

FDA 510(k) clearance K152519 for MTR550 (Tentative) Antimicrobial Silver Wound Gel, Substantially Equivalent on 2016-06-02. Applicant: Medical Technology Research, Inc..

Clearance details

Applicant: Medical Technology Research, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2015-09-03
Decision date: 2016-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodburn, OR, 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.