0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
K-Number: K161996 · 2017-02-16
ApplicantAmend Surgical, Inc.
Decision Date2017-02-16
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is a medical device manufactured by Amend Surgical, Inc.. It received FDA 510(k) clearance on 2017-02-16 under approval number K161996. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Amend Surgical, Inc.. The 510(k) number is K161996.
When was 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE approved by the FDA?
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE received FDA 510(k) clearance on 2017-02-16, under approval number K161996.
What company makes 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is manufactured by Amend Surgical, Inc..
What is the FDA product code for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?
The FDA product code for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE is MQV.
Related Devices (Code: MQV)
Official Source
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