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Veloxion 2490

by Aulea Medical, Inc.

Veloxion 2490 is a Class II device made by Aulea Medical, Inc., cleared under FDA 510(k) K230205 on 24 Feb 2023 and listed in FDA GUDID since 3 Jan 2025 (UDI-DI 00860011104407), active as of 22 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 22 Oct 2026

Documents

510(k) K230205

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860011104407 UDI-DI Date3 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK230205 Date24 Feb 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230205 decided 24 Feb 2023 Active
  • FDA GUDID UDI-DI 00860011104407 listed 3 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230205
  2. Listed FDA GUDID 00860011104407

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Veloxion
Generic name
Resectoscope
Model / Ref / Catalog
2490
Primary DI / UDI-DI
00860011104407
510(k) Number
FDA product code
FJL
GMDN term
Resectoscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Resectoscope

Cleared under the same submission (K230205)

and 1 more cleared under K230205

Similar devices

Other devices filed under FDA product code FJL (Resectoscope).

Other devices from Aulea Medical, Inc.

  • Veloxion 2516

    Class II

  • Veloxion 1877

    Class II

  • Veloxion 1878

    Class II

  • Veloxion 3199

    Class II

See all devices from Aulea Medical, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)