Cleared Traditional

SafeAir Smoke Evacuator compact

K182224 · Lina Medical Aps · General Hospital
Feb 2019
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K182224 is an FDA 510(k) clearance for the SafeAir Smoke Evacuator compact, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Lina Medical Aps (Tarnowo Podgorne, PL). The FDA issued a Cleared decision on February 7, 2019, 175 days after receiving the submission on August 16, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number K182224 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2018
Decision Date February 07, 2019
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYD — Apparatus, Exhaust, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5070

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