K260108
- 510(k) number
- K260108
- Device name
- L12 LED Light Source with AIM
- Applicant
- Stryker Endoscopy CA · US
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2026-02-12
- Date received
- 2026-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260108.pdf
Official FDA record: K260108
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.