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510(k) K231418

ENDOGATOR™ Hybrid Irrigation Tubing by Medivators — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2023
Date Received
May 16, 2023
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 Medivators

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  • K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)
  • K162128 — Scope Buddy Plus Endoscope Flushing Aid (December 21, 2016)
  • K160846 — AmplifEYE (July 14, 2016)
  • K152394 — Rapicide PA High-Level Disinfectant Test Strips (March 11, 2016)
  • K151522 — DEFENDO Bronchoscopy Suction Valve (September 17, 2015)
  • K133724 — MINNCARE HD (August 27, 2014)
  • K140753 — ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM (July 15, 2014)
  • K993042 — MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (August 17, 2000)

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)