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510(k) K242586

ArgoCap (200.52) by Ovesco Endoscopy AG — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2025
Date Received
August 30, 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.

Other clearances by Ovesco Endoscopy AG

  • K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) (December 18, 2025)
  • K241858 — BARS Set (100.60) (August 26, 2024)
  • K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (August 11, 2022)
  • K200684 — gastroduodenal FTRD Set (June 2, 2020)
  • K183309 — stentfix OTSC System Set (October 22, 2019)
  • DEN160014 — remOVE System (December 22, 2017)
  • K170867 — FTRD System Set (July 25, 2017)
  • K153550 — FTRD System Set (October 12, 2016)
  • K150067 — OTSC Proctology (September 16, 2015)
  • K141790 — AQANIFE (March 6, 2015)

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