K233333
- 510(k) number
- K233333
- Device name
- KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2023-11-21
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233333.pdf
Official FDA record: K233333
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.