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FDA 510(k)

Life Saving Tourniquet

K-Number: K254060 · 2026-04-03

ApplicantTW Medical
Decision Date2026-04-03
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Life Saving Tourniquet is the device name listed in this FDA 510(k) record. The listed applicant is TW Medical. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K254060. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Life Saving Tourniquet?

Life Saving Tourniquet is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is TW Medical. The 510(k) number is K254060.

When did Life Saving Tourniquet receive FDA 510(k) clearance?

Life Saving Tourniquet received FDA 510(k) clearance on 2026-04-03, under 510(k) number K254060.

Who is the listed applicant for Life Saving Tourniquet?

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

What is the FDA product code for Life Saving Tourniquet?

The FDA product code for Life Saving Tourniquet is DXC.

Related Devices (Code: DXC)

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.

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