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510(k) K222734

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing by Diversatek Healthcare — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2022
Date Received
September 9, 2022
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.

Other clearances by Diversatek Healthcare

  • K230056 — MiVu™ Esophageal Endo Cap (April 25, 2023)
  • DEN180067 — Mucosal Integrity Conductivity (MI) Test System (December 23, 2019)
  • K190208 — Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (October 3, 2019)

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)
  • K242357 — Water Container (MAJ-901); Water Container (MAJ-902) (October 7, 2024)
  • 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)