Smoklean Surgical Exhaust Apparatus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Smoklean EUDAMED
- Model / Reference
- SJ-SF-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806182200229 EUDAMED
- Basic UDI-DI
- B-08806182200229 EUDAMED
- 510(k) Number
- K173108 FDA 510(k)
- FDA Product Code
- FYD FDA 510(k)
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5070 FDA 510(k)
- Regulation Number
- 878.5070 FDA 510(k)
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
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.
Frequently asked questions
What types of surgical procedures is the Smoklean Surgical Exhaust Apparatus designed to support, and how does it improve the operating room environment?
The Smoklean is designed for use in surgical settings, specifically supporting general and plastic surgery procedures. It functions as an exhaust system to remove smoke, fumes, and airborne contaminants generated during these procedures, thereby improving operating room air quality. By capturing and filtering particulate matter, it helps reduce exposure to harmful substances for both healthcare personnel and patients, creating a safer environment.
Is the Smoklean a single-use or reusable device, and what maintenance is required to ensure its proper function?
The Smoklean is supplied as a reusable system, meaning it is intended for repeated use in surgical settings. To ensure effective operation and longevity, it requires proper installation and maintenance as outlined by the manufacturer. This includes regular cleaning, inspection, and adherence to guidelines provided by Sejong Medical Co., Ltd.
Does the Smoklean come with any specific storage or handling instructions, particularly regarding its reusable nature?
While the provided data does not explicitly detail storage instructions, as a reusable device, the Smoklean must be stored in a clean, dry environment when not in use to prevent contamination or damage. The manufacturer’s guidelines likely include specific recommendations for cleaning, disinfection, and storage to maintain functionality and hygiene, so reviewing those instructions is essential before use.
Is the Smoklean compatible with MRI environments, and what safety considerations should be noted during its use?
The Smoklean is explicitly not MRI-safe, meaning it should not be used in or near MRI environments. When operating, it must be installed and maintained according to manufacturer guidelines to ensure optimal performance and safety for both patients and staff.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173108 | Class II | Active |
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Manufacturer
- Manufacturer
- Sejong Medical Co., Ltd
- FDA Applicant
- Sejong Medical Co., Ltd.
Sources (2)
- FDA 510(k) K173108 24 fields · synced Sep 18, 2026
- EUDAMED e0af40dd-c3e1-43e4-88b5-4d31a81d22e2 61 fields · synced Jul 17, 2026