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FDA 510(k)

Siren SGT

K 號:K220218 · 2022-05-18

決定日期2022-05-18
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

Siren SGT is the device name listed in this FDA 510(k) record. The listed applicant is Tools For Surgery, LLC. It received FDA 510(k) clearance on 2022-05-18 under 510(k) number K220218. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Siren SGT?

Siren SGT is a medical device that received FDA 510(k) clearance on 2022-05-18. The listed applicant is Tools For Surgery, LLC. The 510(k) number is K220218.

When did Siren SGT receive FDA 510(k) clearance?

Siren SGT received FDA 510(k) clearance on 2022-05-18, under 510(k) number K220218.

Who is the listed applicant for Siren SGT?

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

What is the FDA product code for Siren SGT?

The FDA product code for Siren SGT is KNT.

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。

其他以 Tools For Surgery, LLC 為申請人之記錄

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:KNT)

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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