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FDA 510(k)

CrossBow 肌膚縫合系統，配適器的 CrossBow 肌膚縫合系統

K 號：K172666 · 2017-12-01

申請人Sutureease, Inc.
決定日期2017-12-01
產品代碼OCW
諮詢委員會GU
決定相當於

器材摘要

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is Sutureease, Inc.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K172666. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor?

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Sutureease, Inc.. The 510(k) number is K172666.

When did CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor receive FDA 510(k) clearance?

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor received FDA 510(k) clearance on 2017-12-01, under 510(k) number K172666.

Who is the listed applicant for CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor?

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

What is the FDA product code for CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor?

The FDA product code for CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor is OCW.

相關臨床試驗

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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