K-number	K172288
Device name	Fusion OMNI Sphincterotome
Applicant	Wilson-Cook Medical Inc./Cook Endoscopy
Product code	KNS
Device class	Class II
Decision date	Apr 17, 2018
Decision	Substantially Equivalent
Regulation	876.4300

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

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 →

Fusion OMNI Sphincterotome

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