Cleared Traditional

PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter

K230547 · Conmed Corporation · General Hospital

Apr 2023

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K230547 is an FDA 510(k) clearance for the PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on April 27, 2023, 58 days after receiving the submission on February 28, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K230547 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2023
Decision Date	April 27, 2023
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
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).