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K Number
K220505
Device Name
ATTIVA
Manufacturer
Italian Engineering srl
Date Cleared
2023-02-09

(352 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) indicated for treatments based on the emission of electromagnetic waves that lead to a rise of internal temperature of tissues involved in the treatment for electrocoagulation and hemostasis. ATTIVA device can be used on adult patients only.

Device Description

ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories)

AI/ML Overview

I am sorry, but the provided text is a standard FDA 510(k) clearance letter and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a device. Therefore, I cannot fulfill your request based on the given input.

§ 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.