AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)— 510(k) K151185

Substantially Equivalent

Abl Medical, LLC

FDA 510(k) clearance K151185 for AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC), Substantially Equivalent on 2016-02-05. Applicant: Abl Medical, LLC.

Clearance details

Applicant: Abl Medical, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2015-05-04
Decision date: 2016-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: American Fork, UT, 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.