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K Number
K023966
Device Name
DISPOSABLE BI-POLAR CABLE
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2003-02-27

(90 days)

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

Disposable Bi-polar cables are used in conjunction with electrosurgery Disposable Di polar cables are accase ectrosurgical power for cauterizing during surgery.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria for a study, device performance data, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request using the provided text. This document is a regulatory approval notice, not a study report.

§ 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.