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K Number
K982884
Device Name
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH
Manufacturer
NEW DEANTRONICS, LTD.
Date Cleared
1998-09-14

(28 days)

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

Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

Device Description

New Deantronics, Inc. Model SB 312 Disposable Hand Switching Pencil, Rocker Switch, two piece.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a "Disposable Hand Switching Pencil, Rocker Switch Two Piece." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

  • Confirming that the device is substantially equivalent to legally marketed predicate devices.
  • Outlining the regulatory class and product code.
  • Listing the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device.
  • Stating the intended use of the device.

Therefore, I cannot provide the requested information based on the input text.

§ 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.