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) K240572

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K240572 for 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), Substantially Equivalent on 2024-07-01. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2024-02-29
Decision date: 2024-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.