FDA 510(k)

STRATAFIX™ 對稱 PDS™ Plus 無節結構組織控制設備

K 號：K252047 · 2026-05-18

決定日期2026-05-18

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

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K252047. 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 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices?

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is ETHICON, Inc.. The 510(k) number is K252047.

When did STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices receive FDA 510(k) clearance?

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices received FDA 510(k) clearance on 2026-05-18, under 510(k) number K252047.

Who is the listed applicant for STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices?

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

What is the FDA product code for STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices?

The FDA product code for STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices is NEW.

其他以 ETHICON, Inc. 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。

K253394包覆維克萊™（多甘膠910）加抗菌縫線 K253572STRATAFIX™螺旋PRONOVA™單向無結紮組織控制裝置 STRATAFIX™螺旋PRONOVA™雙向無結紮組織控制裝置 K253852MONOCRYL™ Plus 抗菌多甘露聚糖 - 25（單絲），无菌合成可吸收外科縫線 K252743STRATAFIX™螺旋PDS™ Plus無結紮組織控制裝置；STRATAFIX™螺旋MONOCRYL™無結紮組織控制裝置 K243897PDS™ Plus 抗菌（多氧烷酮）无菌合成可吸收外科縫線 K221744STRATAFIX™螺旋MONOCRYL™ Plus無結紮組織控制裝置

查看所有 29 項裝置 →

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.K243897PDS™ Plus 抗菌（多氧烷酮）无菌合成可吸收外科縫線ETHICON, Inc.K251414Miracu™ 多氧二环酮 (PDO) 緝線及針 (單線)Feeltech Co., Ltd.

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。