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FDA 510(k)

SiJoin®T3

K 號:K213815 · 2023-03-29

決定日期2023-03-29
產品代碼OUR
諮詢委員會或
決定相當於

器材摘要

SiJoin®T3 is the device name listed in this FDA 510(k) record. The listed applicant is Vgi Medical, Inc.. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K213815. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SiJoin®T3?

SiJoin®T3 is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Vgi Medical, Inc.. The 510(k) number is K213815.

When did SiJoin®T3 receive FDA 510(k) clearance?

SiJoin®T3 received FDA 510(k) clearance on 2023-03-29, under 510(k) number K213815.

Who is the listed applicant for SiJoin®T3?

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

What is the FDA product code for SiJoin®T3?

The FDA product code for SiJoin®T3 is OUR.

相關臨床試驗

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。

相關器械(代碼:OUR)

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。

官方來源

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