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510(k) K241704

Endoscopic Water Pump by Hangzhou AGS MedTech Co., Ltd. — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2025
Date Received
June 13, 2024
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 Hangzhou AGS MedTech Co., Ltd.

  • K252271 — Hemoclip (November 12, 2025)
  • K222421 — Sphincterotome (May 3, 2023)
  • K221713 — Polypectomy Snare (March 3, 2023)
  • K213143 — Hemoclip (July 12, 2022)
  • K213578 — Balloon Dilatation Catheter (April 6, 2022)
  • K211787 — Hemoclip (March 3, 2022)
  • K210406 — Bipolar Coagulation Foreceps (October 5, 2021)
  • K201121 — Sphincterotome (February 5, 2021)
  • K202237 — Locking device (December 23, 2020)
  • K201509 — Disposable Stone Extraction basket (December 16, 2020)

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)
  • 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)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)
  • K231418 — ENDOGATOR™ Hybrid Irrigation Tubing (August 14, 2023)