FDA 510(k)

Sniper釘針系統

K 號：K162354 · 2017-04-20

決定日期2017-04-20

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

Sniper Staple System is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K162354. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sniper Staple System?

Sniper Staple System is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K162354.

When did Sniper Staple System receive FDA 510(k) clearance?

Sniper Staple System received FDA 510(k) clearance on 2017-04-20, under 510(k) number K162354.

Who is the listed applicant for Sniper Staple System?

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

What is the FDA product code for Sniper Staple System?

The FDA product code for Sniper Staple System is JDR.

其他以 Trilliant Surgical, Ltd. 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。

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相關器械（代碼：JDR）

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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