FDA 510(k)

AbClose - 積極關閉設備

K 號：K160117 · 2016-09-09

決定日期2016-09-09

產品代碼OCW

諮詢委員會GU

決定相當於

器材摘要

AbClose - Port Site Closure Device is the device name listed in this FDA 510(k) record. The listed applicant is Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K160117. 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 AbClose - Port Site Closure Device?

AbClose - Port Site Closure Device is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Medeon Biodesign, Inc.. The 510(k) number is K160117.

When did AbClose - Port Site Closure Device receive FDA 510(k) clearance?

AbClose - Port Site Closure Device received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160117.

Who is the listed applicant for AbClose - Port Site Closure Device?

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

What is the FDA product code for AbClose - Port Site Closure Device?

The FDA product code for AbClose - Port Site Closure Device is OCW.

其他以 Medeon Biodesign, 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。

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相關器械（代碼：OCW）

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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