FDA 510(k)

釘織套件

K 號：K191317 · 2019-07-12

決定日期2019-07-12

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

StitchKit is the device name listed in this FDA 510(k) record. The listed applicant is Origami Surgical. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K191317. 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 StitchKit?

StitchKit is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Origami Surgical. The 510(k) number is K191317.

When did StitchKit receive FDA 510(k) clearance?

StitchKit received FDA 510(k) clearance on 2019-07-12, under 510(k) number K191317.

Who is the listed applicant for StitchKit?

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

What is the FDA product code for StitchKit?

The FDA product code for StitchKit is NBY.

其他以 Origami Surgical 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。

K202950釘合套件 COMBO

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.K181578DemeTECH PTFE 不吸收性外科縫線Demetech Corporation K180630聚四氟乙烯外科縫線Omnia Spa K173922C-PTFETM 外科縫線Cp Medical, Inc.

官方來源

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