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Uniblocker 9.0Fr

by Fuji Systems Corp. 2 variants

Uniblocker 9.0Fr (1203105) is a Class II device made by Fuji Systems Corp., cleared under FDA 510(k) K894337 on 29 Sep 1989 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 04544050063715), 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) K894337

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 Number04544050063715 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK894337 Date29 Sep 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K894337 decided 29 Sep 1989 Active
  • FDA GUDID UDI-DI 04544050063715 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K894337
  2. Listed FDA GUDID 04544050063715

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Uniblocker
Generic name
Bronchial balloon catheter
Model / Ref / Catalog
9.0FR, 1203105
Primary DI / UDI-DI
04544050063715
510(k) Number
FDA product code
CBI
GMDN term
Bronchial balloon catheter
Device class
Class II
Regulation number
868.5740
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Bronchial balloon catheter

Cleared under the same submission (K894337)

and 8 more cleared under K894337

Similar devices

Other devices filed under FDA product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)).

Other devices from Fuji Systems Corp.

See all devices from Fuji Systems Corp. →

Properties

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