Instinct Plus內視鏡夾合器
K 號：K192697 · 2020-03-05
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器材摘要
Instinct Plus Endoscopic Clipping Device is the device name listed in this FDA 510(k) record. The listed applicant is Cook Endoscopy. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K192697. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Instinct Plus Endoscopic Clipping Device?
Instinct Plus Endoscopic Clipping Device is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Cook Endoscopy. The 510(k) number is K192697.
When did Instinct Plus Endoscopic Clipping Device receive FDA 510(k) clearance?
Instinct Plus Endoscopic Clipping Device received FDA 510(k) clearance on 2020-03-05, under 510(k) number K192697.
Who is the listed applicant for Instinct Plus Endoscopic Clipping Device?
The FDA 510(k) record lists Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Instinct Plus Endoscopic Clipping Device?
The FDA product code for Instinct Plus Endoscopic Clipping Device is PKL.
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。
相關器械（代碼：PKL）
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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