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K Number
K021299
Device Name
CONMED HEATWAVE HAND-CONTROLLED ELETRODE
Manufacturer
CONMED CORP.
Date Cleared
2002-06-26

(63 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

For electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures. Additionally, the SI version also has suction capability.

Device Description

Not Found

AI/ML Overview

This is a regulatory letter from the FDA regarding the Conmed Heatwave Hand-Controlled Electrode. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it mention AI-related performance or studies.

Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence determination for a traditional electrosurgical device based on pre-amendment devices, not on performance studies with acceptance criteria, human readers, or AI.

§ 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.