Cleared Traditional

K233789 - 8Q10 Surclear Smoke Plume Evacuation System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K233789 is an FDA 510(k) clearance for the 8Q10 Surclear Smoke Plume Evacuation System. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Surnic Corporation (Brea, US). The FDA issued a Cleared decision on April 10, 2024 after a review of 134 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Surnic Corporation devices

Submission Details

510(k) Number K233789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 128d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYD Apparatus, Exhaust, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYD Apparatus, Exhaust, Surgical

All 74
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K233789.
PlumeSafe X5 Smoke Management System
K240127 · Conmed Corporation · Aug 2024
Medline Smoke Evacuation Shroud
K213068 · Medline Industries, Inc. · Jan 2022
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
K202944 · Northgate Technologies, Inc. · Mar 2021
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
K200250 · Megadyne Medical Products, Inc. · Jun 2020