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FDA 510(k)

STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices，STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices，STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices，STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices

K 號：K182873 · 2019-01-10

申請人ETHICON, Inc.
決定日期2019-01-10
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, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL 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 2019-01-10 under 510(k) number K182873. 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 Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices?

STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is ETHICON, Inc.. The 510(k) number is K182873.

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

STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices received FDA 510(k) clearance on 2019-01-10, under 510(k) number K182873.

Who is the listed applicant for STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL 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, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices?

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

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K252047STRATAFIX™ 對稱 PDS™ Plus 無節結構組織控制設備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

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 CorporationK253879單點固定 PDOSamyang Holdings CorporationK261988Monodek™（多迪氧烷）染綠紫色單絲合成可吸收外科縫線Teleflex Medical, LLCK252171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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