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K Number
K990586
Device Name
CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
Manufacturer
CONMED CORP.
Date Cleared
1999-05-17

(83 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

Sterile, single-use electrosurgical accessory used in conjunction with an ABC® generator for delivery of agron gas and electrosurgical current through a flexible endoscope to perform coagulation.

Device Description

ConMed ABC® Probe for Flexible Endoscopes

AI/ML Overview

This document is a marketing clearance letter from the FDA for the ConMed ABC® Probe for Flexible Endoscopes. It does not contain information about acceptance criteria or specific study details that would allow me to populate the requested table and answer the questions. The letter primarily confirms that the device is substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information 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.