FDA 510(k)

PDS Plus 抗菌（多氧烷酮）无菌合成可吸收外科縫線

K 號：K212380 · 2022-02-22

決定日期2022-02-22

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

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K212380. 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 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is ETHICON, Inc.. The 510(k) number is K212380.

When did PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture receive FDA 510(k) clearance?

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture received FDA 510(k) clearance on 2022-02-22, under 510(k) number K212380.

Who is the listed applicant for PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

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 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

The FDA product code for PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture 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 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

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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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