Back to free search
Home / Search / K050534

XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

Abbott Laboratories · Class II · Cleared May 20, 2005

K-numberK050534
Device nameXPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
ApplicantAbbott Laboratories
Product codeFGE
Device classClass II
Decision dateMay 20, 2005
DecisionUnknown
Regulation876.5010
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 →