Cleared Special

EVA15

K202799 · Palliare , Ltd. · Obstetrics & Gynecology
Oct 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K202799 is an FDA 510(k) clearance for the EVA15, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Palliare , Ltd. (Galway, IE). The FDA issued a Cleared decision on October 21, 2020, 28 days after receiving the submission on September 23, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number K202799 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2020
Decision Date October 21, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIF — Insufflator, Laparoscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1730

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