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K Number
K100258
Device Name
ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200
Manufacturer
WICKIMED SUPPLY LIMITED
Date Cleared
2010-04-28

(90 days)

Product Code
GEI
Regulation Number
878.4400
Type
Abbreviated
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. Normally, it operates under a frequency range of 0.2 – 5 MHz with a maximum peak-to-peak voltage level of 9000V. The maximum power of the device is under 400watts.

By pressing the Yellow and Blue buttons on the pencil, it performs to CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation. Making use of suitable detachable electrode, it fits various kind of application requirement.

Device Description

The electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. Normally, it operates under a frequency range of 0.2 – 5 MHz with a maximum peak-to-peak voltage level of 9000V. The maximum power of the device is under 400watts.

By pressing the Yellow and Blue buttons on the pencil, it performs to CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation. Making use of suitable detachable electrode, it fits various kind of application requirement.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for an electrosurgical pencil. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. This document is a regulatory approval letter, not a study report or technical specification.

Therefore, I cannot provide the requested information from the given text.

To address your request, I would need a different type of document, such as:

  • A clinical study report
  • A validation study protocol or report
  • A performance specification document
  • A 510(k) summary (which might contain a brief summary of performance data, though often not in the detail you're asking for).

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.