Phantom XL绝缘扩张器
K号: K231691 · 2023-06-29
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决定日期2023-06-29
产品代码GXZ
咨询委员会NE
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器械摘要
Phantom XL Insulated Dilators is the device name listed in this FDA 510(k) record. The listed applicant is TeDan Surgical Innovations, Inc.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231691. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Phantom XL Insulated Dilators?
Phantom XL Insulated Dilators is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is TeDan Surgical Innovations, Inc.. The 510(k) number is K231691.
When did Phantom XL Insulated Dilators receive FDA 510(k) clearance?
Phantom XL Insulated Dilators received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231691.
Who is the listed applicant for Phantom XL Insulated Dilators?
The FDA 510(k) record lists TeDan Surgical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Phantom XL Insulated Dilators?
The FDA product code for Phantom XL Insulated Dilators is GXZ.
相关临床试验
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相关器械（代码：GXZ）
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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