SchurSign Tissue Marker— 510(k) K230836

Substantially Equivalent

Surgmark GmbH

FDA 510(k) clearance K230836 for SchurSign Tissue Marker, Substantially Equivalent on 2024-01-23. Applicant: Surgmark GmbH.

Clearance details

Applicant: Surgmark GmbH
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2023-03-27
Decision date: 2024-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

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.