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K Number
K981589
Device Name
ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES
Manufacturer
CONWAY STUART MEDICAL, INC.
Date Cleared
1998-07-30

(87 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

Indicated for coagulation of tissue

These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Description

Electrosurgical Basket Electrodes

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for "Electrosurgical Basket Electrodes" and an associated "Indications for Use" document. This type of document is an FDA clearance and does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

Therefore, I cannot provide the requested information based on the input.

To answer your request, I would need a document that describes:

  • A specific device that uses AI or has performance criteria requiring a study.
  • The acceptance criteria for that device.
  • Details of a study performed to demonstrate conformance to those acceptance criteria.

§ 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.