FDA 510(k)

LS-5 ePTFE 緝線

K 號：K163639 · 2017-06-02

決定日期2017-06-02

產品代碼NBY

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

LS-5 ePTFE Suture is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Solutions. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K163639. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LS-5 ePTFE Suture?

LS-5 ePTFE Suture is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Lsi Solutions. The 510(k) number is K163639.

When did LS-5 ePTFE Suture receive FDA 510(k) clearance?

LS-5 ePTFE Suture received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163639.

Who is the listed applicant for LS-5 ePTFE Suture?

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

What is the FDA product code for LS-5 ePTFE Suture?

The FDA product code for LS-5 ePTFE Suture is NBY.

其他以 Lsi Solutions 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。

K203081RAM COR-SUTURE 快速上線外科縫線，COR-SUTURE 快速上線外科縫線

相關器械（代碼：NBY）

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。

K231277組織統計器Durastat, LLC K192088GOLNIT 非吸收性聚四氟乙烯外科縫線Antarma, LLC Dba Golnit Sutures K180992生物特克斯Purgo Biologics, Inc.K191317釘織套件Origami Surgical K181578DemeTECH PTFE 不吸收性外科縫線Demetech Corporation K180630聚四氟乙烯外科縫線Omnia Spa

官方來源

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