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Attiva MD01

by Italian Engineering SRL

Attiva MD01 is a Class II device made by Italian Engineering SRL, cleared under FDA 510(k) K220505 on 9 Feb 2023 and listed in FDA GUDID since 20 Mar 2023 (UDI-DI 08055510890087), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K220505

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08055510890087 UDI-DI Date20 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220505 Date9 Feb 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220505 decided 9 Feb 2023 Active
  • FDA GUDID UDI-DI 08055510890087 listed 20 Mar 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220505
  2. Listed FDA GUDID 08055510890087

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Attiva
Generic name
Percutaneous radio-frequency ablation system generator
Model / reference
MD01
Primary DI / UDI-DI
08055510890087
510(k) Number
FDA product code
GEI
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Size
Weight — 5.8 Kilogram
Length — 38.5 Centimeter
Height — 10 Centimeter
Width — 20.5 Centimeter

Similar devices in this category

Other devices filed under Percutaneous radio-frequency ablation system generator.

Other devices from Italian Engineering SRL

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Properties

  • Prescription use
Other properties (14, all answered No)