Kumcs-6002SNK

• FDA 510(k) K131028 decided 10 Apr 2014 Active
• FDA GUDID UDI-DI 04961333243327 listed 14 Mar 2018 Listed

• • 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.

1. 11 Jan 2011 Recall initiated FDA recalls Z-2325-2017
2. 11 Jan 2011 Recall initiated FDA recalls Z-2326-2017
3. 11 Jan 2011 Recall initiated FDA recalls Z-2324-2017
4. 10 Apr 2014 Cleared FDA 510(k) K131028
5. 6 Apr 2016 Recall initiated FDA recalls Z-2065-2016
6. 6 Apr 2016 Recall initiated FDA recalls Z-2076-2016
7. 31 May 2016 Recall initiated FDA recalls Z-2875-2016
8. 14 Mar 2018 Listed FDA GUDID 04961333243327

Generic name

Endoscope cleaning brush, reusable

Model / reference

KUMCS-6002SNK

Primary DI / UDI-DI

04961333243327

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

Outer Diameter — 6.0 Millimeter

Length — 20.0 Centimeter

Category: Endoscope cleaning brush, reusable

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• 10386A by Karl Storz SE & CO. KG
• Monarch Platform by Auris Health, Inc.
• BIOPSY FORCEPS, (NON-RIGID) by Portlyn Corp.

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See all devices from PENTAX of America Inc. →