DeviceClearance

Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10) +4 more— 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) +4 more, Substantially Equivalent on 2024-07-01. Applicant: Covidien, LLC. Device class: 2.

Clearance details

Device name as filed
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
Product code
Code GEI
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lafayette, CO, US
Download summary PDFView on FDA.gov ↗

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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, through . 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.