FDA 510(k)

Firebow Wire Torque Assist Device

K-Number: K170684 · 2017-06-29

Decision Date2017-06-29

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Firebow Wire Torque Assist Device is the device name listed in this FDA 510(k) record. The listed applicant is Vesatek, LLC. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K170684. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firebow Wire Torque Assist Device?

Firebow Wire Torque Assist Device is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Vesatek, LLC. The 510(k) number is K170684.

When did Firebow Wire Torque Assist Device receive FDA 510(k) clearance?

Firebow Wire Torque Assist Device received FDA 510(k) clearance on 2017-06-29, under 510(k) number K170684.

Who is the listed applicant for Firebow Wire Torque Assist Device?

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

What is the FDA product code for Firebow Wire Torque Assist Device?

The FDA product code for Firebow Wire Torque Assist Device is DQX.

Other records listing Vesatek, LLC as applicant

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.