K-number	K925608
Device name	SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT
Applicant	Scimed Life Systems, Inc.
Product code	MFY
Device class	Class II
Decision date	Jun 16, 1993
Decision	Unknown
Regulation	870.4075

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 →

SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT

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