END 200 Endoscopic Tubeset— 510(k) K202922

Substantially Equivalent

Palliare , Ltd.

FDA 510(k) clearance K202922 for END 200 Endoscopic Tubeset, Substantially Equivalent on 2021-07-08. Applicant: Palliare , Ltd.. Device class: 2.

Clearance details

Applicant: Palliare , Ltd.
Product code: Code FCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-09-29
Decision date: 2021-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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