BEACON TISSUE MARKER— 510(k) K130763

Substantially Equivalent

Scion Medical Technologies, LLC

FDA 510(k) clearance K130763 for BEACON TISSUE MARKER, Substantially Equivalent on 2013-05-08. Applicant: Scion Medical Technologies, LLC.

Clearance details

Applicant: Scion Medical Technologies, LLC
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2013-03-20
Decision date: 2013-05-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Sauk Centre, MN, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.