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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Amend Surgical, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) 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. The listed applicant is Amend Surgical, Inc.. The 510(k) number is K161996.

When did 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE receive FDA 510(k) clearance?

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE received FDA 510(k) clearance on 2017-02-16, under 510(k) number K161996.

Who is the listed applicant for 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE?

The FDA 510(k) record lists Amend Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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