ARJORAD STERILE WRAP— 510(k) K110954

Substantially Equivalent

Arjo Wiggins Medical, Inc.

FDA 510(k) clearance K110954 for ARJORAD STERILE WRAP, Substantially Equivalent on 2012-08-24. Applicant: Arjo Wiggins Medical, Inc..

Clearance details

Applicant: Arjo Wiggins Medical, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2011-04-05
Decision date: 2012-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.