Monocryl Plus 抗菌縫線
K 號：K201996 · 2020-12-21
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器材摘要
Monocryl Plus Antibacterial Suture is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2020-12-21 under 510(k) number K201996. 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 Monocryl Plus Antibacterial Suture?
Monocryl Plus Antibacterial Suture is a medical device that received FDA 510(k) clearance on 2020-12-21. The listed applicant is ETHICON, Inc.. The 510(k) number is K201996.
When did Monocryl Plus Antibacterial Suture receive FDA 510(k) clearance?
Monocryl Plus Antibacterial Suture received FDA 510(k) clearance on 2020-12-21, under 510(k) number K201996.
Who is the listed applicant for Monocryl Plus Antibacterial Suture?
The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Monocryl Plus Antibacterial Suture?
The FDA product code for Monocryl Plus Antibacterial Suture is GAM.
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。
其他以 ETHICON, 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。
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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