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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Nanosonics Limited. It received FDA 510(k) clearance on 2026-03-05 under 510(k) 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. The listed applicant is Nanosonics Limited. The 510(k) number is K253267.

When did CORIS System receive FDA 510(k) clearance?

CORIS System received FDA 510(k) clearance on 2026-03-05, under 510(k) number K253267.

Who is the listed applicant for CORIS System?

The FDA 510(k) record lists Nanosonics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORIS System?

The FDA product code for CORIS System is SEW.

Other records listing Nanosonics Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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