Name: Predicase
Price: 199 USD

K-number	K161996
Device name	0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
Applicant	Amend Surgical, Inc.
Product code	MQV
Device class	Class II
Decision date	Feb 16, 2017
Decision	Substantially Equivalent
Regulation	888.3045

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 →

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

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