IMAGE1 (TC400US); X-to-4U Adapter (TC040)— 510(k) K253972

Substantially Equivalent

Karl Storz SE & CO. KG

FDA 510(k) clearance K253972 for IMAGE1 (TC400US); X-to-4U Adapter (TC040), Substantially Equivalent on 2026-02-12. Applicant: Karl Storz SE & CO. KG.

Clearance details

Applicant: Karl Storz SE & CO. KG
Product code: Code OWN
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-11
Decision date: 2026-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

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.