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510(k) K202838

Andorate Universal Endoscope Tip Guard by Ga Health Company Limited — Product Code OCU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2021
Date Received
September 25, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Storage Cover
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.

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  • 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 OCU

  • K191715 — Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile (January 27, 2020)
  • K191011 — Scope ProTech (May 7, 2019)
  • K030684 — SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH (June 3, 2003)
  • K951104 — ENDOBOOT (April 6, 1995)
  • K940780 — SCOPEJOCKEY (May 10, 1994)