Pump In Style® Pro+
K号: K253498 · 2026-01-22
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申请人Medela, LLC
决定日期2026-01-22
产品代码HGX
咨询委员会OB
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决定实质等同
器械摘要
Pump In Style® Pro+ is the device name listed in this FDA 510(k) record. The listed applicant is Medela, LLC. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K253498. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pump In Style® Pro+?
Pump In Style® Pro+ is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Medela, LLC. The 510(k) number is K253498.
When did Pump In Style® Pro+ receive FDA 510(k) clearance?
Pump In Style® Pro+ received FDA 510(k) clearance on 2026-01-22, under 510(k) number K253498.
Who is the listed applicant for Pump In Style® Pro+?
The FDA 510(k) record lists Medela, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pump In Style® Pro+?
The FDA product code for Pump In Style® Pro+ is HGX.
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Medela, LLC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：HGX）
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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