FDA 510(k)

Snowden-Pencer 微創3mm 腹腔鏡器械

K 號：K163615 · 2017-05-04

決定日期2017-05-04

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Snowden-Pencer MicroLap 3mm 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 2017-05-04 under 510(k) number K163615. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Snowden-Pencer MicroLap 3mm Laparoscopic Instruments?

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K163615.

When did Snowden-Pencer MicroLap 3mm Laparoscopic Instruments receive FDA 510(k) clearance?

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments received FDA 510(k) clearance on 2017-05-04, under 510(k) number K163615.

Who is the listed applicant for Snowden-Pencer MicroLap 3mm 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 MicroLap 3mm Laparoscopic Instruments?

The FDA product code for Snowden-Pencer MicroLap 3mm Laparoscopic Instruments is GEI.

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。

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相關器械（代碼：GEI）

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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