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510(k) K230932

ANDORATE® Valve Kit by Ga Health Company Limited — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2023
Date Received
April 3, 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 Ga Health Company Limited

  • K232118 — ANDORATE® Valve Kit (October 16, 2023)
  • K231602 — Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tub (August 1, 2023)
  • K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (May 11, 2023)
  • K223171 — AquaPulse® Irrigation Tubing (November 10, 2022)
  • K213095 — andorate Suction Valve, andorate Air/Water Valve (January 12, 2022)
  • K202838 — Andorate Universal Endoscope Tip Guard (March 5, 2021)
  • K202560 — AquaPulse Irrigation Tubing (December 10, 2020)
  • K200495 — Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve (June 24, 2020)
  • K200481 — Andorate Biopsy Valve, Andorate Biopsy Irrigator (June 18, 2020)
  • K200479 — AquaPulse Auxiliary Water Connector (May 15, 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)
  • 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)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)