K232327

Endorail

510(k) number
K232327
Device name
Endorail
Applicant
Endostart S.R.L. IT
Product code
ODC — Endoscope Channel Accessory
Decision date
2024-03-15
Date received
2023-08-03
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain

Also available from FDA: K232327.pdf

Official FDA record: K232327
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.