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Solero 12740000US

by Angiodynamics, Inc.

Solero 12740000US is a Class II device made by Angiodynamics, Inc., cleared under FDA 510(k) K162449 on 5 May 2017 and listed in FDA GUDID since 10 May 2017 (UDI-DI H78712740000US0), active as of 23 Oct 2026. 9 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

510(k) K162449

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 NumberH78712740000US0 UDI-DI Date10 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162449 Date5 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162449 decided 5 May 2017 Active
  • FDA GUDID UDI-DI H78712740000US0 listed 10 May 2017 Listed

Recalls

9 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2439-2021 FDA Class II initiated 20 Jul 2021
    • Terminated Z-2436-2021 FDA Class II initiated 20 Jul 2021
    • Terminated Z-2438-2021 FDA Class II initiated 20 Jul 2021
    • Terminated Z-2437-2021 FDA Class II initiated 20 Jul 2021

    Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.

  • 5 recalls, same reason

    • Terminated Z-1701-2019 FDA Class II initiated 17 Apr 2019
    • Terminated Z-1702-2019 FDA Class II initiated 17 Apr 2019
    • Terminated Z-1703-2019 FDA Class II initiated 17 Apr 2019
    • Terminated Z-1700-2019 FDA Class II initiated 17 Apr 2019
    • Terminated Z-1704-2019 FDA Class II initiated 17 Apr 2019

    Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Timeline

11 dated events

  1. Listed FDA GUDID H78712740000US0
  2. Recall initiated FDA recalls Z-1701-2019
  3. Recall initiated FDA recalls Z-1702-2019
  4. Recall initiated FDA recalls Z-1703-2019
  5. Recall initiated FDA recalls Z-1700-2019
  6. Recall initiated FDA recalls Z-1704-2019
  7. Recall initiated FDA recalls Z-2439-2021
  8. Recall initiated FDA recalls Z-2436-2021
  9. Recall initiated FDA recalls Z-2438-2021
  10. Recall initiated FDA recalls Z-2437-2021

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Solero
Generic name
Microwave hyperthermia system
Model / reference
12740000US
Primary DI / UDI-DI
H78712740000US0
510(k) Number
FDA product code
NEY
GMDN term
Microwave hyperthermia system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Microwave hyperthermia system

Cleared under the same submission (K162449)

Other devices from Angiodynamics, Inc.

See all devices from Angiodynamics, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)