K-number	K082831
Device name	AMSELF CLOSED CATHETERIZATION SYSTEM
Applicant	Amsino International, Inc.
Product code	FCM
Device class	Class II
Decision date	Oct 23, 2008
Decision	Substantially Equivalent
Regulation	876.5130

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 →

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 →

AMSELF CLOSED CATHETERIZATION SYSTEM

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