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510(k) K232244

Disposable Endoscope Valves System by Changzhou Endoclean Medical Device Co., Ltd. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2023
Date Received
July 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by Changzhou Endoclean Medical Device Co., Ltd.

  • K221310 — Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing (October 7, 2022)
  • K221331 — Disposable Endoscope Valves System (September 8, 2022)

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  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si (March 22, 2024)