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510(k) K112318

CLEARPATH 24 by Promedic, Inc. — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2012
Date Received
August 11, 2011
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 Promedic, Inc.

  • K131889 — EUM 100PRO (April 23, 2014)
  • K072756 — NON-IV ADAPTER FOR INFANT NG TUBE (December 19, 2007)
  • K060497 — BABYAIR (July 11, 2006)
  • K060842 — REVJET TURBO (June 21, 2006)
  • K052903 — PEDIATRIC FEEDING TUBE (November 9, 2005)
  • K031409 — URINARY CATHETERS (June 17, 2003)
  • K024190 — FENESTRATED INFUSION CATHETER (March 17, 2003)
  • K023579 — GAS SAMPLING LINES (January 28, 2003)
  • K020005 — INFANT FEEDING TUBES (July 16, 2002)
  • K970102 — FILTER (June 24, 1997)

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)