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FDA 510(k)

InZone Detachment System

K-Number: K160096 · 2016-02-19

Decision Date2016-02-19
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

InZone Detachment System is a medical device manufactured by Stryker Neurovascular. It received FDA 510(k) clearance on 2016-02-19 under approval number K160096. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InZone Detachment System?

InZone Detachment System is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Stryker Neurovascular. The 510(k) number is K160096.

When was InZone Detachment System approved by the FDA?

InZone Detachment System received FDA 510(k) clearance on 2016-02-19, under approval number K160096.

What company makes InZone Detachment System?

InZone Detachment System is manufactured by Stryker Neurovascular.

What is the FDA product code for InZone Detachment System?

The FDA product code for InZone Detachment System is HCG.

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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.