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K Number
K971540
Device Name
AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD
Manufacturer
AMERICAN BIOSURGICAL, INC.
Date Cleared
1997-08-14

(108 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

To transfer electrical current from generator to a surgical instrument

Device Description

Monopolar Cable

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Monopolar Cable and does not contain the detailed information required to fulfill the request. The letter confirms substantial equivalence but does not describe acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for a device's performance.

Therefore, I cannot provide the requested information based on the given 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.