510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240018Unknown

CORIS System

Nanosonics Limited, Macquarie Park, AU / Direct, Unknown
FDA source (opens on fda.gov)

DEN240018 is the FDA 510(k) clearance record for CORIS System, a class II device, cleared for Nanosonics Limited on under FDA product code SEW (Automated Endoscope Channel Cleaner). FDA's definition for product code SEW reads: "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...". FDA records list 7 510(k) clearances for Nanosonics Limited, from to . As of , FDA records show no recalls naming DEN240018.

Clearance record

Decision date
Received
(322 days to decision)
Product code
SEW Automated Endoscope Channel Cleaner
Regulation
21 CFR 880.6994
Device class
Class II
Review panel
General Hospital
Applicant
Nanosonics Limited 7-11 Talavera Rd., Macquarie Park, AU
Third party review
No

Clearances, product code SEW

Trailing 12 months
1 clearance under product code SEW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SEW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260