FDA 510(k)

釘織套件

K 號：K211792 · 2021-07-16

決定日期2021-07-16

產品代碼GAM

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 Inc .. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K211792. The device is classified under product code GAM. 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 2021-07-16. The listed applicant is Origami Surgical Inc .. The 510(k) number is K211792.

When did StitchKit receive FDA 510(k) clearance?

StitchKit received FDA 510(k) clearance on 2021-07-16, under 510(k) number K211792.

Who is the listed applicant for StitchKit?

The FDA 510(k) record lists Origami Surgical Inc . 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 GAM.

其他以 Origami Surgical 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。

K221527釘織套件

相關器械（代碼：GAM）

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。

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官方來源

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