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FDA 510(k)

LiteSaber Wire Torque Assist Device

K-Number: K200120 · 2020-05-07

ApplicantVesatek, LLC
Decision Date2020-05-07
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LiteSaber Wire Torque Assist Device is a medical device manufactured by Vesatek, LLC. It received FDA 510(k) clearance on 2020-05-07 under approval number K200120. 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 LiteSaber Wire Torque Assist Device?

LiteSaber Wire Torque Assist Device is a medical device that received FDA 510(k) clearance on 2020-05-07. It is manufactured by Vesatek, LLC. The 510(k) number is K200120.

When was LiteSaber Wire Torque Assist Device approved by the FDA?

LiteSaber Wire Torque Assist Device received FDA 510(k) clearance on 2020-05-07, under approval number K200120.

What company makes LiteSaber Wire Torque Assist Device?

LiteSaber Wire Torque Assist Device is manufactured by Vesatek, LLC.

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

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

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Related PubMed Literature

PMID: 40060767 Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation. Bioengineering & translational medicine (2025)

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K170684Firebow Wire Torque Assist Device

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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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