UriSponge™
K号: K232565 · 2024-10-11
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决定日期2024-10-11
产品代码JSM
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器械摘要
UriSponge™ is the device name listed in this FDA 510(k) record. The listed applicant is Copan Italia Spa. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K232565. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UriSponge™?
UriSponge™ is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Copan Italia Spa. The 510(k) number is K232565.
When did UriSponge™ receive FDA 510(k) clearance?
UriSponge™ received FDA 510(k) clearance on 2024-10-11, under 510(k) number K232565.
Who is the listed applicant for UriSponge™?
The FDA 510(k) record lists Copan Italia Spa as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UriSponge™?
The FDA product code for UriSponge™ is JSM.
相关临床试验
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。
列明Copan Italia Spa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。
相关器械（代码：JSM）
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
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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