K-number	DEN240018
Device name	CORIS System
Applicant	Nanosonics Limited
Product code	SEW
Device class	Class II
Decision date	Mar 19, 2025
Decision	Not Substantially Equivalent
Regulation	880.6994

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

CORIS System

Everything you need for a 510(k) submission. Nothing you don't.