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510(k) K203630

BioGuard Air/Water and Suction Valves by Steris Corporations — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2021
Date Received
December 11, 2020
Clearance Type
Special
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.

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  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
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  • 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)