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Fujifilm Sb-602

by Fujifilm Corporation

Ref 04547410132786

Fujifilm Sb-602 is an endoscope suction valve (EU MDR Class I; FDA Class II; FDA product code EOQ, Bronchoscope (Flexible or Rigid)) made by Fujifilm Corporation, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 454741020100000000001365F), cleared under FDA 510(k) K122535 on 13 Dec 2012 and listed in FDA GUDID since 21 Nov 2016 (UDI-DI 04547410132786), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122535

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741020100000000001365F Basic UDI-DI 04547410132786UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410132786 UDI-DI Date21 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122535 Date13 Dec 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000001365F registered 13 Oct 2026 Active
  • FDA 510(k) K122535 decided 13 Dec 2012 Active
  • FDA GUDID UDI-DI 04547410132786 listed 21 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122535
  2. Listed FDA GUDID 04547410132786
  3. Registered EUDAMED 454741020100000000001365F

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Single Use Suction Button SB-602 EUDAMED
Fujifilm GUDID
Generic name
Endoscope suction valve, single-use
Device name
Single Use Suction Button 1
Model / reference
04547410132786 EUDAMED
SB-602 GUDID
Primary DI / UDI-DI
04547410132786
Basic UDI-DI
454741020100000000001365F
510(k) Number
FDA product code
EOQ
EMDN code
K01020199 Minimally invasive surgery surgical instrument kits, single-use - other
GMDN term
Endoscope suction valve, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4680
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04547410132786
GUDID
SB-602
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Endoscope suction valve, single-use

Cleared under the same submission (K122535)

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER.

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 (19, all answered No)