FDA 510(k)

Zimmon針刀皮脫刀

K 號：K171993 · 2017-08-17

申請人Wilson-Cook Medical Inc./Cook Endoscopy

決定日期2017-08-17

產品代碼KNS

諮詢委員會GU

決定相當於

器材摘要

Zimmon Needle Knife Papillotome is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K171993. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zimmon Needle Knife Papillotome?

Zimmon Needle Knife Papillotome is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K171993.

When did Zimmon Needle Knife Papillotome receive FDA 510(k) clearance?

Zimmon Needle Knife Papillotome received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171993.

Who is the listed applicant for Zimmon Needle Knife Papillotome?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zimmon Needle Knife Papillotome?

The FDA product code for Zimmon Needle Knife Papillotome is KNS.

其他以 Wilson-Cook Medical Inc./Cook Endoscopy 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。

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相關器械（代碼：KNS）

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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