Name: Predicase
Price: 199 USD

K-number	K170897
Device name	Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
Applicant	B.Braun Medical, Inc.
Product code	PTI
Device class	Class II
Decision date	Nov 3, 2017
Decision	Substantially Equivalent
Regulation	880.5570

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 →

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site

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