Name: Predicase
Price: 199 USD

K-number	K113422
Device name	TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE
Applicant	Terumo (Philippines) Corporation
Product code	FMI
Device class	Class II
Decision date	Mar 5, 2012
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 →

TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE

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