Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSM…
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K240572 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Valleylab SM Smoke Management Pencil with Edge Blade Electrode is a monopolar electrosurgical device designed for smoke evacuation. It combines electrosurgical functionality with integrated smoke capture, enabling simultaneous cutting, coagulation, and smoke removal during surgical procedures. The extended nozzles (VSMEN4 and VSMEN6) are compatible with 4” (100mm) and 6.5” (165mm) electrodes, respectively, to enhance reach and adaptability. This device is categorized under general electrosurgical tools and is intended for use in conjunction with an effective smoke evacuation system.
The device is supplied in sterile and non-sterile configurations, with lengths of 10’ (3m) and 15’ (4.6m) for the pencil variants. The extended nozzles (VSMEN4 and VSMEN6) are reusable accessories designed for compatibility with the specified electrode sizes. It is classified under FDA 510(k) clearance (K240572) as substantially equivalent to a predicate device, with authorization for general plastic surgery applications. Storage and handling follow standard sterile medical device protocols, and MRI safety considerations must be evaluated per manufacturer guidelines.
Frequently asked questions
What is the Valleylab SM Smoke Management Pencil with Edge Blade Electrode used for?
This device is designed for monopolar electrosurgical procedures where smoke evacuation is required. It allows simultaneous cutting, coagulation, and smoke removal, reducing operating room air contamination during surgeries like plastic procedures. The integrated smoke management feature helps maintain visibility and air quality while performing precise tissue manipulation.
How is the Valleylab SM Smoke Management Pencil supplied, and what are the length options?
The device is available in sterile and non-sterile configurations. The pencil variants come in two lengths: 10 feet (3 meters) for models VSMP10 and VSMP10NSB (non-sterile bulk), and 15 feet (4.6 meters) for model VSMP15. The extended nozzles (VSMEN4 and VSMEN6) are reusable accessories and are not supplied with the pencil but are designed for compatibility with specific electrode sizes.
Are the extended nozzles reusable, and what electrode sizes do they accommodate?
Yes, the extended nozzles (VSMEN4 and VSMEN6) are reusable accessories. The VSMEN4 nozzle is designed for use with a 4” (100mm) electrode, while the VSMEN6 nozzle is intended for a 6.5” (165mm) electrode. These nozzles enhance the reach and adaptability of the pencil during surgical procedures, allowing for better maneuverability in confined spaces.
How should the Valleylab SM Smoke Management Pencil be stored?
The device should be stored according to standard sterile medical device protocols if in a sterile configuration. Non-sterile bulk items (like VSMP10NSB) should be stored in a clean, dry environment, protected from contamination and physical damage. Always follow manufacturer guidelines for proper handling, including any specific instructions related to packaging integrity or environmental conditions.
What regulatory clearance does the Valleylab SM Smoke Management Pencil hold?
The device holds FDA 510(k) clearance (K240572) under the classification of general electrosurgical tools, with a decision of substantial equivalence to a predicate device. This clearance is specifically for general plastic surgery applications, ensuring it meets regulatory standards for safety and performance in those contexts.
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. Sources consulted: Valleylab™ SM smoke management pencil - Medtronic, Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10 ..., PDF K240572 ValleylabTM SM Smoke Management Pencil with EdgeTM Blade ..., PDF Miranda Miles - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240572 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K240572 24 fields · synced Oct 1, 2026