FDA 510(k)

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments

K号: K163615 · 2017-05-04

决定日期2017-05-04

产品代码GEI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Carefusion 2200, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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