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510(k) K140753

ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM by Medivators — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2014
Date Received
March 26, 2014
Clearance Type
Special
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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  • K223040 — Endo SmartCap (March 1, 2023)
  • 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)
  • K993042 — MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (August 17, 2000)

Other clearances for product code OCX

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  • 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)