範圍Seal十二指腸內視鏡保護裝置
K 號：K183171 · 2019-10-08
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器材摘要
ScopeSeal Duodenoscope Protective Device is the device name listed in this FDA 510(k) record. The listed applicant is Gi Scientific, LLC. It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K183171. The device is classified under product code ODB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ScopeSeal Duodenoscope Protective Device?
ScopeSeal Duodenoscope Protective Device is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Gi Scientific, LLC. The 510(k) number is K183171.
When did ScopeSeal Duodenoscope Protective Device receive FDA 510(k) clearance?
ScopeSeal Duodenoscope Protective Device received FDA 510(k) clearance on 2019-10-08, under 510(k) number K183171.
Who is the listed applicant for ScopeSeal Duodenoscope Protective Device?
The FDA 510(k) record lists Gi Scientific, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ScopeSeal Duodenoscope Protective Device?
The FDA product code for ScopeSeal Duodenoscope Protective Device is ODB.
相關臨床試驗
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相關器械（代碼：ODB）
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。
官方來源
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