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FDA 510(k)

Cytrans™ Elashield

K-Number: K253317 · 2026-07-06

ApplicantGC America, Inc.
Decision Date2026-07-06
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cytrans™ Elashield is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2026-07-06 under 510(k) number K253317. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cytrans™ Elashield?

Cytrans™ Elashield is a medical device that received FDA 510(k) clearance on 2026-07-06. The listed applicant is GC America, Inc.. The 510(k) number is K253317.

When did Cytrans™ Elashield receive FDA 510(k) clearance?

Cytrans™ Elashield received FDA 510(k) clearance on 2026-07-06, under 510(k) number K253317.

Who is the listed applicant for Cytrans™ Elashield?

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

What is the FDA product code for Cytrans™ Elashield?

The FDA product code for Cytrans™ Elashield is LYC.

Other records listing GC America, Inc. as applicant

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Related Devices (Code: LYC)

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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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