CORIS System
K-Number: K253267 · 2026-03-05
ApplicantNanosonics Limited
Decision Date2026-03-05
Product CodeSEW
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
CORIS System is a medical device manufactured by Nanosonics Limited. It received FDA 510(k) clearance on 2026-03-05 under approval number K253267. The device is classified under product code SEW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CORIS System?
CORIS System is a medical device that received FDA 510(k) clearance on 2026-03-05. It is manufactured by Nanosonics Limited. The 510(k) number is K253267.
When was CORIS System approved by the FDA?
CORIS System received FDA 510(k) clearance on 2026-03-05, under approval number K253267.
What company makes CORIS System?
CORIS System is manufactured by Nanosonics Limited.
What is the FDA product code for CORIS System?
The FDA product code for CORIS System is SEW.
Other Devices by Nanosonics Limited
Related Devices (Code: SEW)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.