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X-Cube

by Saeshin Precision Co., Ltd. 2 variants

X-Cube is a Class I device made by Saeshin Precision Co., Ltd., cleared under FDA 510(k) K092758 on 21 Sep 2009 and listed in FDA GUDID since 22 Jan 2020 (UDI-DI 08809260470293), 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) K092758

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 Number08809260470293 UDI-DI Date22 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK092758 Date21 Sep 2009IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092758 decided 21 Sep 2009 Active
  • FDA GUDID UDI-DI 08809260470293 listed 22 Jan 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092758
  2. Listed FDA GUDID 08809260470293

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
5-Nucleotidase IVD, calibrator
Model / reference
X-CUBE
Primary DI / UDI-DI
08809260470293
510(k) Number
FDA product code
EBW
GMDN term
5-Nucleotidase IVD, calibrator
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: 5-Nucleotidase IVD, calibrator

Cleared under the same submission (K092758)

Similar devices

Other devices filed under FDA product code EBW (Controller, Foot, Handpiece And Cord).

Other devices from Saeshin Precision Co., Ltd.

See all devices from Saeshin Precision Co., Ltd. →

Properties

  • Serial number
Other properties (14, all answered No)