EVA15— 510(k) K202799

Name: FDA 510(k) clearance K202799
Creator: U.S. Food and Drug Administration
Published: 2020-10-21

Substantially Equivalent

Palliare , Ltd.

FDA 510(k) clearance K202799 for EVA15, Substantially Equivalent on 2020-10-21. Applicant: Palliare , Ltd.. Device class: 2.

Clearance details

Applicant: Palliare , Ltd.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2020-09-23
Decision date: 2020-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIF

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K260209 — ENDOFLATOR+; Smart Smoke Evacuation2026-08-19
K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)2026-06-25
K252318 — Insufflator (OPTO-IFL1000)2026-04-16
K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

More clearances from Palliare , Ltd.

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K232902 — EVA15 insufflator2024-05-02
K230474 — EVA5 Insufflator2023-03-24
K222901 — EVA15 insufflator2023-01-27
K202922 — END 200 Endoscopic Tubeset2021-07-08
K193520 — EVA 15 Insufflator2020-07-23

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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