Cleared Traditional

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)

K240572 · Covidien, LLC · General & Plastic Surgery

Jul 2024

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K240572 is an FDA 510(k) clearance for the 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), a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Covidien, LLC (Lafayette, US). The FDA issued a Cleared decision on July 1, 2024, 123 days after receiving the submission on February 29, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K240572 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 29, 2024
Decision Date	July 01, 2024
Days to Decision	123 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).