Name: Predicase
Price: 199 USD

K-number	K252752
Device name	ellacor System with Micro-Coring Technology
Applicant	Cytrellis Biosystems, Inc.
Product code	QAI
Device class	Class II
Decision date	Oct 30, 2025
Decision	Substantially Equivalent
Regulation	878.4430

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

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 →

ellacor System with Micro-Coring Technology

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