Cleared Traditional

K230547 - 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 is an FDA 510(k) clearance for PlumePen Elite Surgical Smoke Evacuatio..., manufactured by Conmed Corporation. The device is a Class 2 General Hospital device with product code GEI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K230547 · Conmed Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
58d
Days
Class 2
Risk

K230547 is an FDA 510(k) clearance for the PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on April 27, 2023 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4400 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conmed Corporation devices

FDA 510(k) Submission Details - K230547

510(k) Number K230547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

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All 1745
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