Endorail— 510(k) K232327

Substantially Equivalent

Endostart S.R.L.

FDA 510(k) clearance K232327 for Endorail, Substantially Equivalent on 2024-03-15. Applicant: Endostart S.R.L.. Device class: 2.

Clearance details

Applicant: Endostart S.R.L.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-08-03
Decision date: 2024-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Certaldo, IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.