FDA 510(k)

C2 冷冻球囊 EndoGrip

K号: K193036 · 2019-11-22

申请人Pentax Medical, A Division of Pentax of America, Inc.

决定日期2019-11-22

产品代码OCX

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

C2 CryoBalloon EndoGrip is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical, A Division of Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K193036. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the C2 CryoBalloon EndoGrip?

C2 CryoBalloon EndoGrip is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Pentax Medical, A Division of Pentax of America, Inc.. The 510(k) number is K193036.

When did C2 CryoBalloon EndoGrip receive FDA 510(k) clearance?

C2 CryoBalloon EndoGrip received FDA 510(k) clearance on 2019-11-22, under 510(k) number K193036.

Who is the listed applicant for C2 CryoBalloon EndoGrip?

The FDA 510(k) record lists Pentax Medical, A Division of Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C2 CryoBalloon EndoGrip?

The FDA product code for C2 CryoBalloon EndoGrip is OCX.

列明Pentax Medical, A Division of Pentax of America, 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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官方来源

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