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Fujifilm Sb-606

by Fujifilm Corporation

Fujifilm Sb-606 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K220957 on 10 Nov 2022 and listed in FDA GUDID since 2 Dec 2022 (UDI-DI 04547410480986), 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) K220957

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 Number04547410480986 UDI-DI Date2 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220957 Date10 Nov 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220957 decided 10 Nov 2022 Active
  • FDA GUDID UDI-DI 04547410480986 listed 2 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220957
  2. Listed FDA GUDID 04547410480986

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  • Withdrawn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
Endoscope suction valve, single-use
Model / reference
SB-606
Primary DI / UDI-DI
04547410480986
510(k) Number
FDA product code
EOQ
GMDN term
Endoscope suction valve, single-use
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope suction valve, single-use

Cleared under the same submission (K220957)

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)