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FDA 510(k)

Checkpoint 監護器手術導線，中號，Checkpoint 監護器手術導線，大號

K 號：K212355 · 2021-08-26

申請人Checkpoint Surgical
決定日期2021-08-26
產品代碼ETN
諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯： 此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。 公司名稱：[公司名稱] 產品名稱：[產品名稱]
決定相當於

器材摘要

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is the device name listed in this FDA 510(k) record. The listed applicant is Checkpoint Surgical. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K212355. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Checkpoint Surgical. The 510(k) number is K212355.

When did Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large receive FDA 510(k) clearance?

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large received FDA 510(k) clearance on 2021-08-26, under 510(k) number K212355.

Who is the listed applicant for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

The FDA 510(k) record lists Checkpoint Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

The FDA product code for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is ETN.

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相關器械（代碼：ETN）

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官方來源

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