FDA 510(k)

TroClose 1200

K 號：K253620 · 2025-12-16

決定日期2025-12-16

產品代碼GAM

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

TroClose 1200 is the device name listed in this FDA 510(k) record. The listed applicant is Gordian Surgical, Ltd.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K253620. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TroClose 1200?

TroClose 1200 is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Gordian Surgical, Ltd.. The 510(k) number is K253620.

When did TroClose 1200 receive FDA 510(k) clearance?

TroClose 1200 received FDA 510(k) clearance on 2025-12-16, under 510(k) number K253620.

Who is the listed applicant for TroClose 1200?

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

What is the FDA product code for TroClose 1200?

The FDA product code for TroClose 1200 is GAM.

其他以 Gordian Surgical, Ltd. 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。

K171494TroClose1200, TroClose1200 管針 K160564TroClose1200

相關器械（代碼：GAM）

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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官方來源

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