ITALIAN ENGINEERING SRL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3012757453	3012757453	ITALIAN ENGINEERING SRL	1	N	2026-01-01	VIA DELL'ELETTRICISTA 38 Bologna IT 40138

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
315149	1454604469	K220505	ATTIVA	GEI	2023-02-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEI	1	2023-02-09

GUDID#

RF BLUNT STRAIGHT CANNULA, 22Gx100mm, ACTIVE TIP 10mm (w holder) - RF BLUNT STRAIGHT CANNULA, 22G x 100mm, ACTIVE TIP 10mm with Holder.Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. To be used only with ATTIVA device (K220505).

ITALIAN ENGINEERING SRL

2023-08-04

RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder) - RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm with Holder.This includes:- RF0M22050R10A- RF0M22100R10A- RF0M20150R10A- RF0M16200R10A.Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. To be used only with ATTIVA device (K220505).

ITALIAN ENGINEERING SRL

2023-03-28

RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w/o Holder) - RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm without Holder.This includes:- RF0M22050R10- RF0M22100R10- RF0M20150R10- RF0M16200R10.Cannulas are closed-end tip, so that the electrodes are never in contact with the patient as they are internal to the closed-end tip cannulas. They are to be used only with ATTIVA device (K220505).

ITALIAN ENGINEERING SRL

2023-03-28

RF THERMOCOUPLE ELECTRODE - The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505)

ITALIAN ENGINEERING SRL

2023-03-28

RF THERMOCOUPLE ELECTRODE - The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505).

ITALIAN ENGINEERING SRL

2023-03-28

RF THERMOCOUPLE ELECTRODE - The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505)

ITALIAN ENGINEERING SRL

2023-03-28

RF THERMOCOUPLE ELECTRODE - The electrode thermocouple measures temperature and, through a feedback circuit, automatically adjusting energy delivery to maintain the set temperature in the tissue. To be used with ATTIVA device (K220505).

ITALIAN ENGINEERING SRL

2023-03-28

INTERMEDIATE CABLE - To be used with ATTIVA device (K220505).

ITALIAN ENGINEERING SRL

2023-03-20

ATTIVA - 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.It comprises of a base unit, activation pedal, ground pad (K203494), endodermic handpiece, thermal camera (K033967) and monitor, and blunt cannulas and RF electrodes.

ITALIAN ENGINEERING SRL

2023-03-20