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510(k) Data Aggregation
K Number
K981589Manufacturer
Date Cleared
1998-07-30
(87 days)
Product Code
Regulation Number
878.4400Type
TraditionalReference & Predicate Devices
N/A
Predicate For
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.
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