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FDA 510(k)

FastStroke

K-Number: K163281 · 2017-01-26

ApplicantGef Medical Systems Scs
Decision Date2017-01-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FastStroke is a medical device manufactured by Gef Medical Systems Scs. It received FDA 510(k) clearance on 2017-01-26 under approval number K163281. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FastStroke?

FastStroke is a medical device that received FDA 510(k) clearance on 2017-01-26. It is manufactured by Gef Medical Systems Scs. The 510(k) number is K163281.

When was FastStroke approved by the FDA?

FastStroke received FDA 510(k) clearance on 2017-01-26, under approval number K163281.

What company makes FastStroke?

FastStroke is manufactured by Gef Medical Systems Scs.

What is the FDA product code for FastStroke?

The FDA product code for FastStroke is JAK.

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Official Source

View on FDA Database →

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

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