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Fujinon G5 Colonoscopes, Models Ec-450HL5 and Ec-250HL5

by Fujinon, Inc.

510(k) K041903

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041903 Date10 Nov 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0708-06 FDA Unclassified (pre-2012) initiated 27 Mar 2006

    Colonoscope insertion tube is not bending properly and is stiff.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FDF
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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