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Smoklean Surgical Exhaust Apparatus

by Sejong Medical Co., Ltd

510(k) K173108Ref SJ-SF-03

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173108↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806182200229 Basic UDI-DI 08806182200229UDI-DIDate28 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK173108 Date18 May 2018ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806182200229 registered 28 May 2026 Active
  • FDA 510(k) K173108 decided 18 May 2018 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K173108
  2. Registered EUDAMED B-08806182200229

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Smoklean
Model / reference
SJ-SF-03
FDA applicant
Sejong Medical Co., Ltd.
Primary DI / UDI-DI
08806182200229
Basic UDI-DI
B-08806182200229
510(k) Number
FDA product code
FYD
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
Device class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.5070
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class I
510(k)
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Smoklean Surgical Exhaust Apparatus is a Class II surgical device designed for the removal of smoke, fumes, and airborne contaminants generated during surgical procedures. It functions as an exhaust system to improve operating room air quality by capturing and filtering particulate matter, reducing exposure to healthcare personnel and patients.

This device is supplied as a reusable system and is intended for use in surgical settings, including general and plastic surgery. It complies with FDA 510(k) clearance under regulation number 878.5070 and the Medical Device Directive (MDD). The apparatus is not MRI-safe and requires proper installation and maintenance as per manufacturer guidelines to ensure effective operation and longevity.

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER.

Other devices from Sejong Medical Co., Ltd

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Properties

  • Supplied sterile
Other properties (11, all answered No)