Skip to content

Cs-6015STK

by PENTAX of America Inc.

Cs-6015STK is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K131028 on 10 Apr 2014 and listed in FDA GUDID since 14 Mar 2018 (UDI-DI 04961333242832), active as of 8 Nov 2026. 6 FDA recalls are 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

None ongoing

6 closed

Documents

510(k) K131028

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333242832 UDI-DI Date14 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131028 Date10 Apr 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131028 decided 10 Apr 2014 Active
  • FDA GUDID UDI-DI 04961333242832 listed 14 Mar 2018 Listed

Recalls

6 recalls · FDA

    • Terminated Z-2875-2016 FDA Class II initiated 31 May 2016

    Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

  • 2 recalls, same reason

    • Terminated Z-2065-2016 FDA Class II initiated 6 Apr 2016
    • Terminated Z-2076-2016 FDA Class II initiated 6 Apr 2016

    Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

  • 3 recalls, same reason

    • Terminated Z-2325-2017 FDA Class II initiated 11 Jan 2011
    • Terminated Z-2326-2017 FDA Class II initiated 11 Jan 2011
    • Terminated Z-2324-2017 FDA Class II initiated 11 Jan 2011

    This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

Timeline

8 dated events

  1. Recall initiated FDA recalls Z-2325-2017
  2. Recall initiated FDA recalls Z-2326-2017
  3. Recall initiated FDA recalls Z-2324-2017
  4. Cleared FDA 510(k) K131028
  5. Recall initiated FDA recalls Z-2065-2016
  6. Recall initiated FDA recalls Z-2076-2016
  7. Recall initiated FDA recalls Z-2875-2016
  8. Listed FDA GUDID 04961333242832

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Endoscope cleaning brush, reusable
Model / reference
CS-6015STK
Primary DI / UDI-DI
04961333242832
FDA product code
EOQ
GMDN term
Endoscope cleaning brush, reusable
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 2.3 Millimeter
Outer Diameter — 6.0 Millimeter
Length — 150.0 Centimeter

Related devices

Category: Endoscope cleaning brush, reusable

Cleared under the same submission (K131028)

and 8 more cleared under K131028

Similar devices

Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (11, all answered No)