Name: Predicase
Price: 199 USD

K-number	K022620
Device name	SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
Applicant	Spire Biomedical, Inc.
Product code	FKA
Device class	Class II
Decision date	Oct 11, 2002
Decision	Substantially Equivalent
Regulation	876.5540

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 →

SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT

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