RZ 切除镜系统
K号: K243382 · 2025-06-03
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决定日期2025-06-03
产品代码HIH
咨询委员会OB
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决定实质等同
器械摘要
RZ Resectoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Rz Medizintechnik GmbH. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K243382. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RZ Resectoscope System?
RZ Resectoscope System is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Rz Medizintechnik GmbH. The 510(k) number is K243382.
When did RZ Resectoscope System receive FDA 510(k) clearance?
RZ Resectoscope System received FDA 510(k) clearance on 2025-06-03, under 510(k) number K243382.
Who is the listed applicant for RZ Resectoscope System?
The FDA 510(k) record lists Rz Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RZ Resectoscope System?
The FDA product code for RZ Resectoscope System is HIH.
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。
相关器械（代码：HIH）
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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