Name: Predicase
Price: 199 USD

K-number	K190715
Device name	EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
Applicant	Interscope, Inc.
Product code	ERL
Device class	Class II
Decision date	Dec 13, 2019
Decision	Substantially Equivalent
Regulation	874.4250

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 →

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

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