Rigi10 可变形阴茎假体
K号: K181673 · 2019-04-15
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决定日期2019-04-15
产品代码FAE
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
Rigi10 Malleable Penile Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Rigicon, Inc.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K181673. The device is classified under product code FAE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Rigi10 Malleable Penile Prosthesis?
Rigi10 Malleable Penile Prosthesis is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Rigicon, Inc.. The 510(k) number is K181673.
When did Rigi10 Malleable Penile Prosthesis receive FDA 510(k) clearance?
Rigi10 Malleable Penile Prosthesis received FDA 510(k) clearance on 2019-04-15, under 510(k) number K181673.
Who is the listed applicant for Rigi10 Malleable Penile Prosthesis?
The FDA 510(k) record lists Rigicon, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rigi10 Malleable Penile Prosthesis?
The FDA product code for Rigi10 Malleable Penile Prosthesis is FAE.
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相关器械（代码：FAE）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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