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Ba-004cc

by Fujifilm Corporation

Ba-004cc is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K261170 on 12 Aug 2026 and listed in FDA GUDID since 1 Sep 2026 (UDI-DI 04547410576610), 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) K261170

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 Number04547410576610 UDI-DI Date1 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK261170 Date12 Aug 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261170 decided 12 Aug 2026 Active
  • FDA GUDID UDI-DI 04547410576610 listed 1 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261170
  2. Listed FDA GUDID 04547410576610

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Needle guide, single-use
Model / reference
BA-004CC
Primary DI / UDI-DI
04547410576610
510(k) Number
FDA product code
ITX
GMDN term
Needle guide, single-use
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

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