Identity
- Trade Name
- ATTIVA FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MD01 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055510890087 FDA UDI
- 510(k) Number
- K220505 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 5.8 Kilogram FDA UDILength — 38.5 Centimeter FDA UDIHeight — 10 Centimeter FDA UDIWidth — 20.5 Centimeter FDA UDI
Category: Percutaneous radio-frequency ablation system generator
Attiva by Italian Engineering Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation system generator.
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- Maestro 4000™ Controller — Boston Scientific · Class III
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- OsteoCool™ 2.0 RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Cleared under the same submission
K220505 also covers:
- INTERMEDIATE CABLE — ITALIAN ENGINEERING SRL
- RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w holder) — ITALIAN ENGINEERING SRL
- RF BLUNT STRAIGHT CANNULA ACTIVE TIP 10mm (w/o Holder) — ITALIAN ENGINEERING SRL
- RF BLUNT STRAIGHT CANNULA, 22Gx100mm, ACTIVE TIP 10mm (w holder) — ITALIAN ENGINEERING SRL
- RF THERMOCOUPLE ELECTRODE — ITALIAN ENGINEERING SRL
- RF THERMOCOUPLE ELECTRODE — ITALIAN ENGINEERING SRL
- RF THERMOCOUPLE ELECTRODE — ITALIAN ENGINEERING SRL
- RF THERMOCOUPLE ELECTRODE — ITALIAN ENGINEERING SRL
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Italian Engineering Srl
Sources (1)
- FDA UDI 9667c2ee-94d3-463d-882c-4afb682fc65d 36 fields · synced Jun 1, 2026