EXTRICARE NPWT FOOT DRESSING— 510(k) K131464

Substantially Equivalent

Devon Medical, Inc.

FDA 510(k) clearance K131464 for EXTRICARE NPWT FOOT DRESSING, Substantially Equivalent on 2013-08-13. Applicant: Devon Medical, Inc..

Clearance details

Applicant: Devon Medical, Inc.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2013-05-21
Decision date: 2013-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: King Of Prussia, PA, US

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Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.