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K Number
K974793
Device Name
ELMED ESU 120 M/M DIGITAL
Manufacturer
ELMED, INC.
Date Cleared
1998-03-19

(87 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

The EIMED ESU 120 M/M DIGITAL is a electrosurgical system designed for surgical procedures to be chosen by licensed surgeons. The unit can be used for unipolar cutting, unipolar micro-coagulation and bimlar coagulation.

Device Description

ELMED ESU 120 M/M DIGITAL is an electrosurgical system.

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the 'ELMED ESU 120 M/M DIGITAL' electrosurgical system. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested table and study details. This document is a regulatory clearance letter, not a scientific 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.