FDA 510(k)

Instinct Plus內視鏡夾合器

K 號：K212323 · 2021-08-25

決定日期2021-08-25

產品代碼PKL

諮詢委員會GU

決定相當於

器材摘要

Instinct Plus Endoscopic Clipping Device is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K212323. 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 2021-08-25. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K212323.

When did Instinct Plus Endoscopic Clipping Device receive FDA 510(k) clearance?

Instinct Plus Endoscopic Clipping Device received FDA 510(k) clearance on 2021-08-25, under 510(k) number K212323.

Who is the listed applicant for Instinct Plus Endoscopic Clipping Device?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. 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.

其他以 Wilson-Cook Medical, Inc. 為申請人之記錄

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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

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