FDA 510(k)

超縫針擴展線

K 號：K234079 · 2024-05-10

決定日期2024-05-10

產品代碼GAT

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

HyperSuture Extension Line is the device name listed in this FDA 510(k) record. The listed applicant is Threadstone, LLC. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K234079. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HyperSuture Extension Line?

HyperSuture Extension Line is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Threadstone, LLC. The 510(k) number is K234079.

When did HyperSuture Extension Line receive FDA 510(k) clearance?

HyperSuture Extension Line received FDA 510(k) clearance on 2024-05-10, under 510(k) number K234079.

Who is the listed applicant for HyperSuture Extension Line?

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

What is the FDA product code for HyperSuture Extension Line?

The FDA product code for HyperSuture Extension Line is GAT.

其他以 Threadstone, 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。

K254275超縫全綠延伸線 K242201HyperSuture 白/綠延伸線 K241376超縫全藍延伸線 K230311超縫合器

相關器械（代碼：GAT）

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。

K253910釘線 - 緝合針線及膠帶GM Dos Reis Industria e Comercio Ltda.K261021EasyWhip 家族Winter Innovations, Inc.K260775聚乙烯；聚乙烯融合；聚乙烯正骨膠帶™Teleflex Medical, LLC K254275超縫全綠延伸線Threadstone, LLC K254188半月板VersaflexGM Dos Reis Industria e Comercio Ltda.K253145預縫合腱Rti Surgical, Inc.

官方來源

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