Cleared Traditional

8Q10 Surclear Smoke Plume Evacuation System

K233789 · Surnic Corporation · General Hospital
Apr 2024
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K233789 is an FDA 510(k) clearance for the 8Q10 Surclear Smoke Plume Evacuation System, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Surnic Corporation (Brea, US). The FDA issued a Cleared decision on April 10, 2024, 134 days after receiving the submission on November 28, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number K233789 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2023
Decision Date April 10, 2024
Days to Decision 134 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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