CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM— 510(k) K081459

Substantially Equivalent

Integra Radionics, Inc.

FDA 510(k) clearance K081459 for CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM, Substantially Equivalent on 2008-08-13. Applicant: Integra Radionics, Inc..

Clearance details

Applicant: Integra Radionics, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2008-05-23
Decision date: 2008-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.