K261890
- 510(k) number
- K261890
- Device name
- 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®
- Applicant
- Boehringer Laboratories, LLC PA · US
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2026-08-14
- Date received
- 2026-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K261890.pdf
Official FDA record: K261890
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.