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510(k) K242357

Water Container (MAJ-901); Water Container (MAJ-902) by Olympus Medical Systems Corporation — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2024
Date Received
August 8, 2024
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.

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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)
  • 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)
  • K231418 — ENDOGATOR™ Hybrid Irrigation Tubing (August 14, 2023)