IMAGE1 (TC400US); X-to-4U Adapter (TC040)— 510(k) K253972
Substantially EquivalentKarl 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. Device class: 2.
Summary
Karl Storz lists IMAGE1 (TC400US) and an X-to-4U Adapter (TC040) under product code OWN, confocal optical imaging. The record doesn't describe either one beyond its name and that code name.
Class II, 21 CFR 876.1500. The General, Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology, Urology as the classification panel.
Karl Storz filed from Tuttlingen, Germany. Review took 63 calendar days (December 11, 2025 to February 12, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Product code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
Recent devices under product code OWN
view allMore clearances from Karl Storz SE & CO. KG
view allAdverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . 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.