Back to free search
Home / Search / K021142

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

Fortune Medical Instrument Corp. · Class II · Cleared Oct 1, 2002

K-numberK021142
Device nameALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
ApplicantFortune Medical Instrument Corp.
Product codeEZL
Device classClass II
Decision dateOct 1, 2002
DecisionSubstantially Equivalent
Regulation876.5130
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 →

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 →