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510(k) K213095

andorate Suction Valve, andorate Air/Water Valve by Ga Health Company Limited — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2022
Date Received
September 24, 2021
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 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)
  • K230932 — ANDORATE® Valve Kit (July 7, 2023)
  • K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (May 11, 2023)
  • K223171 — AquaPulse® Irrigation Tubing (November 10, 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 ODC

  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • 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)