Name: Predicase
Price: 199 USD

K-number	K171040
Device name	Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
Applicant	Koelis
Product code	ITX
Device class	Class II
Decision date	Jul 31, 2017
Decision	Substantially Equivalent
Regulation	892.1570

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 →

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range

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