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K Number
K984552
Device Name
COOL-TIP RF SYSTEM
Manufacturer
RADIONICS, INC.
Date Cleared
1999-03-05

(73 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

The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for the Radionics, Inc. Cool-Tip RF System, dated March 5, 1999. This document only states the FDA's finding of substantial equivalence based on a premarket notification. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.

The letter focuses on the regulatory aspects of the device, indicating that it is substantially equivalent to a predicate device and can therefore be marketed.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving the device meets those criteria from 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.