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Fujifilm Eb-710P

by Fujifilm Corporation

Fujifilm Eb-710P is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K244017 on 13 Jun 2025 (1 earlier submission) and listed in FDA GUDID since 2 Dec 2022 (UDI-DI 04547410482478), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK244017 Date13 Jun 2025DecidedStatusActive
United StatesGUDID listing Number04547410482478 UDI-DI Date2 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K244017 decided 13 Jun 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04547410482478 listed 2 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220957
  2. Listed FDA GUDID 04547410482478
  3. Cleared FDA 510(k) K244017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fujifilm
Generic name
Flexible video bronchoscope, reusable
Model / reference
EB-710P
Primary DI / UDI-DI
04547410482478
510(k) Number
FDA product code
EOQ
GMDN term
Flexible video bronchoscope, reusable
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)