K232857
- 510(k) number
- K232857
- Device name
- KARL STORZ ICG Imaging System
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2023-11-06
- Date received
- 2023-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232857.pdf
Official FDA record: K232857
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.