K240572

Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6)

510(k) number: K240572
Device name: Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6)
Applicant: Covidien, LLC CO · US
Product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date: 2024-07-01
Date received: 2024-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K240572.pdf

Official FDA record: K240572

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.