Name: Predicase
Price: 199 USD

K-number	K132181
Device name	GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
Applicant	Olympus Surgical Technologies America
Product code	EZN
Device class	Class II
Decision date	Oct 21, 2013
Decision	Substantially Equivalent
Regulation	876.5470

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 →

GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER

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