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510(k) K231471

Air/Water Bottle Tubing, CO2 Source Tubing by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2023
Date Received
May 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Irrigation/Suction System
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

Other clearances by Zhejiang Chuangxiang Medical Technology Co., Ltd.

  • K253132 — Single use stone retrieval balloons (March 6, 2026)
  • K251890 — Disposable Ureteral Stents (February 20, 2026)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K220063 — Single Use Cytology Brush (July 28, 2022)
  • K212669 — Single Use Hemoclip (May 27, 2022)
  • K220065 — Single Use Ureteral Access Sheath (May 25, 2022)
  • K212668 — Sclerotherapy Needle (February 23, 2022)
  • K191900 — Single Use Grasping Forceps (March 27, 2020)
  • K192258 — Disposable Valve Sets (December 30, 2019)
  • K173758 — Disposable Biopsy Valve (May 14, 2018)

Other clearances for product code OCX

  • K251986 — AUXILIARY WATER TUBE MAJ-855 (September 26, 2025)
  • K251997 — Single-Use Biopsy Valve (MAJ-1555) (September 25, 2025)
  • K242586 — ArgoCap (200.52) (May 22, 2025)
  • K241704 — Endoscopic Water Pump (March 20, 2025)
  • K242357 — Water Container (MAJ-901); Water Container (MAJ-902) (October 7, 2024)
  • K241874 — Aspiration Catheter (2189) (September 24, 2024)
  • K242134 — ClearCap Distal Attachment (August 20, 2024)
  • K233442 — troCarWash™ System (May 21, 2024)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K231418 — ENDOGATOR™ Hybrid Irrigation Tubing (August 14, 2023)