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)

FDA 510(k) clearance K240572 · decided 2024-07-01

Clearance details

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

Decision

Substantially Equivalent

Date received

2024-02-29

Decision date

2024-07-01

Days to decision

123 days

Clearance type

Traditional

Product code

GEI

Device class

2

Regulation number

878.4400

Medical specialty

General, Plastic Surgery

Advisory committee

General, Plastic Surgery

Location

Lafayette, CO, US

Third-party review

No

Expedited review

No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant