FDA 510(k)

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K 號：K242835 · 2025-01-22

決定日期2025-01-22

產品代碼NEW

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

Suture-TOOL System is the device name listed in this FDA 510(k) record. The listed applicant is Suturion AB. It received FDA 510(k) clearance on 2025-01-22 under 510(k) number K242835. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Suture-TOOL System?

Suture-TOOL System is a medical device that received FDA 510(k) clearance on 2025-01-22. The listed applicant is Suturion AB. The 510(k) number is K242835.

When did Suture-TOOL System receive FDA 510(k) clearance?

Suture-TOOL System received FDA 510(k) clearance on 2025-01-22, under 510(k) number K242835.

Who is the listed applicant for Suture-TOOL System?

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

What is the FDA product code for Suture-TOOL System?

The FDA product code for Suture-TOOL System is NEW.

其他以 Suturion AB 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。

K250977縫合工具系統

相關器械（代碼：NEW）

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。

K254238MINT MONO 緝合針Hans Biomed Corporation K253879單點固定 PDOSamyang Holdings Corporation K261988Monodek™（多迪氧烷）染綠紫色單絲合成可吸收外科縫線Teleflex Medical, LLC K252171針刺型PDO縫線Sutura Medical Technology, Inc.K252047STRATAFIX™ 對稱 PDS™ Plus 無節結構組織控制設備ETHICON, Inc.K243897PDS™ Plus 抗菌（多氧烷酮）无菌合成可吸收外科縫線ETHICON, Inc.

官方來源

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