Back to free search
Home / Search / K251104

SureTome™ SW Sphincterotome with DomeTip

Wilson-Cook Medical · Class II · Cleared Sep 29, 2025

K-numberK251104
Device nameSureTome™ SW Sphincterotome with DomeTip
ApplicantWilson-Cook Medical
Product codeKNS
Device classClass II
Decision dateSep 29, 2025
DecisionSubstantially Equivalent
Regulation876.4300
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 →

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

14-day free trial. No setup. Cancel anytime.

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 →