K253972
- 510(k) number
- K253972
- Device name
- IMAGE1 (TC400US); X-to-4U Adapter (TC040)
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2026-02-12
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253972.pdf
Official FDA record: K253972
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.