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510(k) K232004

Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector by Medivators (A Subsidiary of Steris Corporation) — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2024
Date Received
July 6, 2023
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 Medivators (A Subsidiary of Steris Corporation)

  • K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si (March 22, 2024)
  • K232329 — Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Ai (December 21, 2023)

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)