FDA 510(k)

Transorb™ 自粘性可吸收網格

K 號：K233661 · 2024-02-13

決定日期2024-02-13

產品代碼OWT

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

Transorb™ Self-Gripping Resorbable Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2024-02-13 under 510(k) number K233661. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Transorb™ Self-Gripping Resorbable Mesh?

Transorb™ Self-Gripping Resorbable Mesh is a medical device that received FDA 510(k) clearance on 2024-02-13. The listed applicant is Sofradim Production. The 510(k) number is K233661.

When did Transorb™ Self-Gripping Resorbable Mesh receive FDA 510(k) clearance?

Transorb™ Self-Gripping Resorbable Mesh received FDA 510(k) clearance on 2024-02-13, under 510(k) number K233661.

Who is the listed applicant for Transorb™ Self-Gripping Resorbable Mesh?

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

What is the FDA product code for Transorb™ Self-Gripping Resorbable Mesh?

The FDA product code for Transorb™ Self-Gripping Resorbable Mesh is OWT.

其他以 Sofradim Production 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。

K253956ProGrip™ 先進自緊握聚丙烯網格 (ADG1510, ADG2015, ADG3020, ADG4030)K250869Parietene™ 大孔網膜 (PPM5050)K243315ProGrip™ 自粘性聚丙烯網 K232373Progrip™ 自攝式聚丙烯網格 K223218帕瑞特尼大孔網 K220586Symbotex複合網膜，ProGrip自握聚酯網膜，Parietex親水性2D 3D解剖網膜，Versatex單絲網膜

查看所有 11 項裝置 →

相關器械（代碼：OWT）

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。

K243241Phasix ST 腹股溝癆補貼Davol, Inc., A Subsidiary of C.R. Bard, Inc.K191749TIGR 矩陣外科網膜，TIGR 外科網膜Novus Scientific AB K191773GORE BIO-A 組織強化劑W. L. Gore & Associates, Inc.K190185Phasix ST 網狀結構搭配開放定位系統C.R. Bard, Inc.K173143Phasix ST 網狀物C.R. Bard, Inc.K163005TIGR 矩陣外科網格Novus Scientific AB

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。