K234033

ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)

510(k) number
K234033
Device name
ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
Applicant
Boehringer Laboratories, LLC PA · US
Product code
KNT — Tubes, Gastrointestinal (And Accessories)
Decision date
2024-05-06
Date received
2023-12-20
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain

Also available from FDA: K234033.pdf

Official FDA record: K234033
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.