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FDA 510(k)

Durashield Device Kit

K-Number: K252995 · 2026-09-17

ApplicantSurGenTec, LLC
Decision Date2026-09-17
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Durashield Device Kit is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K252995. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Durashield Device Kit?

Durashield Device Kit is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is SurGenTec, LLC. The 510(k) number is K252995.

When did Durashield Device Kit receive FDA 510(k) clearance?

Durashield Device Kit received FDA 510(k) clearance on 2026-09-17, under 510(k) number K252995.

Who is the listed applicant for Durashield Device Kit?

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

What is the FDA product code for Durashield Device Kit?

The FDA product code for Durashield Device Kit is GZT.

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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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