FDA 510(k)

Cytrans™ Elashield

K 號：K253317 · 2026-07-06

決定日期2026-07-06

產品代碼LYC

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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?

FDA 510(k) 記錄將 GC America, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Cytrans™ Elashield?

The FDA product code for Cytrans™ Elashield is LYC.

其他以 GC America, Inc. 為申請人之記錄

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相關器械（代碼：LYC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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