LaparoGuard
K 號：K182434 · 2018-12-13
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器材摘要
LaparoGuard is the device name listed in this FDA 510(k) record. The listed applicant is Mariner Endosurgery, Inc.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K182434. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LaparoGuard?
LaparoGuard is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Mariner Endosurgery, Inc.. The 510(k) number is K182434.
When did LaparoGuard receive FDA 510(k) clearance?
LaparoGuard received FDA 510(k) clearance on 2018-12-13, under 510(k) number K182434.
Who is the listed applicant for LaparoGuard?
The FDA 510(k) record lists Mariner Endosurgery, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LaparoGuard?
The FDA product code for LaparoGuard is GCJ.
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相關器械（代碼：GCJ）
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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