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K Number
K992345
Device Name
CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
Manufacturer
INNERVISION, INC.
Date Cleared
1999-09-10

(89 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 Christoudias Slim Tip Electrode Insert is indicated for laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Christoudias Slim Tip Electrode Insert." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods typical for AI/ML device evaluations. Such details are usually found in the 510(k) submission summary or the actual study reports, not in the clearance letter itself.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on 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.