EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET— 510(k) K122619

Substantially Equivalent

Applied Medical

FDA 510(k) clearance K122619 for EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET, Substantially Equivalent on 2012-10-02. Applicant: Applied Medical.

Clearance details

Applicant: Applied Medical
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2012-08-28
Decision date: 2012-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.