Radiopaque Tissue Marker— 510(k) K170026

Substantially Equivalent

Viscus Biologics, LLC

FDA 510(k) clearance K170026 for Radiopaque Tissue Marker, Substantially Equivalent on 2017-06-02. Applicant: Viscus Biologics, LLC.

Clearance details

Applicant: Viscus Biologics, LLC
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2017-01-03
Decision date: 2017-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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.