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FDA 510(k)

Snowden-Pencer 人體工學式可拆式直徑及手槍式內視鏡手術器械

K 號:K151036 · 2016-02-01

決定日期2016-02-01
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) number K151036. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K151036.

When did Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments receive FDA 510(k) clearance?

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments received FDA 510(k) clearance on 2016-02-01, under 510(k) number K151036.

Who is the listed applicant for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

The FDA product code for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is GCJ.

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。

其他以 Carefusion 2200, Inc. 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。

相關器械(代碼:GCJ)

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。

官方來源

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