Name: Predicase
Price: 199 USD

K-number	K221872
Device name	ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
Applicant	Nova Eye Inc. (Business Name Nova Eye Medical)
Product code	MPA
Device class	Class II
Decision date	Mar 30, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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 →

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

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