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K Number
K030831
Device Name
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2004-06-15

(459 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

The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.

Device Description

Not Found

AI/ML Overview

This document is a letter from the FDA regarding clearance for "Laparoscopic Instruments and Electrode Tips" and an "Indications for Use" statement. It does not contain information about acceptance criteria or a study proving how the device meets those criteria. Therefore, I cannot extract the requested information from the provided 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.