CORIS System— 510(k) K253267

Substantially Equivalent

Nanosonics Limited

FDA 510(k) clearance K253267 for CORIS System, Substantially Equivalent on 2026-03-05. Applicant: Nanosonics Limited. Device class: 2.

Clearance details

Applicant: Nanosonics Limited
Product code: Code SEW
Device class: Class 2
Regulation: 21 CFR 880.6994
Advisory panel: General Hospital
Date received: 2025-09-29
Decision date: 2026-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Macquarie Park, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code SEW

DEN240018 — CORIS System2025-03-19

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Data sourced from openFDA. This site is unofficial and independent of the FDA.