FDA 510(k)

精準點針穿刺針導向器

K 號：K160414 · 2016-08-01

決定日期2016-08-01

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

Precision Point Biopsy Needle Guide is the device name listed in this FDA 510(k) record. The listed applicant is Corbin Clinical Resources, LLC. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K160414. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Precision Point Biopsy Needle Guide?

Precision Point Biopsy Needle Guide is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Corbin Clinical Resources, LLC. The 510(k) number is K160414.

When did Precision Point Biopsy Needle Guide receive FDA 510(k) clearance?

Precision Point Biopsy Needle Guide received FDA 510(k) clearance on 2016-08-01, under 510(k) number K160414.

Who is the listed applicant for Precision Point Biopsy Needle Guide?

The FDA 510(k) record lists Corbin Clinical Resources, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Point Biopsy Needle Guide?

The FDA product code for Precision Point Biopsy Needle Guide is ITX.

其他以 Corbin Clinical Resources, LLC 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。

K160423會陰通路針

相關器械（代碼：ITX）

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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