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510(k) DEN240018

CORIS System by Nanosonics Limited — Product Code SEW

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 19, 2025
Date Received
May 1, 2024
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Endoscope Channel Cleaner
Device Class
Class II
Regulation Number
880.6994
Review Panel
HO
Submission Type

An automated endoscope channel cleaner is a device intended to replace all or a portion of manual cleaning of internal passages and ports of compatible reusable flexible endoscopes. Cleaning is conducted using an agent that exerts physical force (e.g., friction) on single or multiple channels of compatible endoscopes for removal of soil. This device type is not intended to provide or replace high-level disinfection or sterilization.

Other clearances by Nanosonics Limited

  • K253267 — CORIS System (March 5, 2026)
  • K241536 — trophon Wireless Ultrasound Probe Holder (September 27, 2024)
  • K173865 — trophon2 (April 24, 2018)
  • K103126 — TROPHON CHEMICAL INDICATOR (March 3, 2011)
  • K103059 — TROPHON (February 24, 2011)

Other clearances for product code SEW

  • K253267 — CORIS System (March 5, 2026)