ATTIVA
Italian Engineering S.R.L.
ITALIAN ENGINEERING SRL
FDA Registration(s)
| 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 | 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 |
|---|---|---|
| GEI | 1 | 2023-02-09 |
PMN
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).
2023-08-04
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)
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).
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)
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).
2023-03-28
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).
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).
2023-03-28
INTERMEDIATE CABLE - To be used with ATTIVA device (K220505).
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.
2023-03-20