FDA 510(k)

Z-Clamp ISP System

K-Number: K161016 · 2016-10-19

Decision Date2016-10-19

Product CodePEK

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Z-Clamp ISP System is a medical device manufactured by Zavation, LLC. It received FDA 510(k) clearance on 2016-10-19 under approval number K161016. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z-Clamp ISP System?

Z-Clamp ISP System is a medical device that received FDA 510(k) clearance on 2016-10-19. It is manufactured by Zavation, LLC. The 510(k) number is K161016.

When was Z-Clamp ISP System approved by the FDA?

Z-Clamp ISP System received FDA 510(k) clearance on 2016-10-19, under approval number K161016.

What company makes Z-Clamp ISP System?

Z-Clamp ISP System is manufactured by Zavation, LLC.

What is the FDA product code for Z-Clamp ISP System?

The FDA product code for Z-Clamp ISP System is PEK.

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Other Devices by Zavation, LLC

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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.