K231854
- 510(k) number
- K231854
- Device name
- 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
- Applicant
- Stryker CA · US
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2023-09-20
- Date received
- 2023-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231854.pdf
Official FDA record: K231854
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.