ENDOGATOR™ 混合灌洗导管
K号: K231418 · 2023-08-14
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申请人Medivators
决定日期2023-08-14
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
ENDOGATOR™ Hybrid Irrigation Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Medivators. It received FDA 510(k) clearance on 2023-08-14 under 510(k) number K231418. 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 ENDOGATOR™ Hybrid Irrigation Tubing?
ENDOGATOR™ Hybrid Irrigation Tubing is a medical device that received FDA 510(k) clearance on 2023-08-14. The listed applicant is Medivators. The 510(k) number is K231418.
When did ENDOGATOR™ Hybrid Irrigation Tubing receive FDA 510(k) clearance?
ENDOGATOR™ Hybrid Irrigation Tubing received FDA 510(k) clearance on 2023-08-14, under 510(k) number K231418.
Who is the listed applicant for ENDOGATOR™ Hybrid Irrigation Tubing?
The FDA 510(k) record lists Medivators as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ENDOGATOR™ Hybrid Irrigation Tubing?
The FDA product code for ENDOGATOR™ Hybrid Irrigation Tubing is OCX.
相关临床试验
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相关器械（代码：OCX）
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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