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Colonovideoscope Olympus Cf-HQ1100DI

by Olympus Medical Systems Corporation

Colonovideoscope Olympus Cf-HQ1100DI (N6019640) is a Class II device made by Olympus Medical Systems Corporation, cleared under FDA 510(k) K222584 on 26 Apr 2023 and listed in FDA GUDID since 4 Jul 2023 (UDI-DI 04953170424298), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K222584

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170424298 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222584 Date26 Apr 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222584 decided 26 Apr 2023 Active
  • FDA GUDID UDI-DI 04953170424298 listed 4 Jul 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0181-2025 FDA Class II initiated 21 Aug 2024

    It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

Timeline

3 dated events

  1. Cleared FDA 510(k) K222584
  2. Listed FDA GUDID 04953170424298
  3. Recall initiated FDA recalls Z-0181-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Colonovideoscope
Generic name
Flexible video colonoscope, reusable
Model / Ref / Catalog
OLYMPUS CF-HQ1100DI, N6019640
Primary DI / UDI-DI
04953170424298
510(k) Number
FDA product code
FDF, FDS, NWB, FET, NTN
GMDN term
Flexible video colonoscope, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible video colonoscope, reusable

Cleared under the same submission (K222584)

and 3 more cleared under K222584

Similar devices

Other devices filed under FDA product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

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