FDA 510(k)

FastStroke

K-Number: K163281 · 2017-01-26

Decision Date2017-01-26

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FastStroke is the device name listed in this FDA 510(k) record. The listed applicant is Gef Medical Systems Scs. It received FDA 510(k) clearance on 2017-01-26 under 510(k) 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. The listed applicant is Gef Medical Systems Scs. The 510(k) number is K163281.

When did FastStroke receive FDA 510(k) clearance?

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

Who is the listed applicant for FastStroke?

The FDA 510(k) record lists Gef Medical Systems Scs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FastStroke?

The FDA product code for FastStroke is JAK.

Related Devices (Code: JAK)

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.