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Fujifilm Eb-530S

by Fujifilm Corporation

Fujifilm Eb-530S is a flexible video bronchoscope (FDA Class II; FDA product code EOQ, Bronchoscope (Flexible or Rigid)) made by Fujifilm Corporation, cleared under FDA 510(k) K122535 on 13 Dec 2012 and listed in FDA GUDID since 14 Dec 2016 (UDI-DI 04547410333312), 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) K122535

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 Number04547410333312 UDI-DI Date14 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122535 Date13 Dec 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122535 decided 13 Dec 2012 Active
  • FDA GUDID UDI-DI 04547410333312 listed 14 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122535
  2. Listed FDA GUDID 04547410333312

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  • Withdrawn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-530S
Primary DI / UDI-DI
04547410333312
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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Other devices filed under Flexible video bronchoscope, reusable.

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)