Cleared Special

EVA5 Insufflator

K230474 · Palliare , Ltd. · Gastroenterology & Urology
Mar 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K230474 is an FDA 510(k) clearance for the EVA5 Insufflator, a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II — Special Controls, product code FCX), submitted by Palliare , Ltd. (Galway, IE). The FDA issued a Cleared decision on March 24, 2023, 30 days after receiving the submission on February 22, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K230474 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2023
Decision Date March 24, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FCX — Insufflator, Automatic Carbon-dioxide For Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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