Pitch PaSoft 软组织加固设备
K号: K230671 · 2023-05-31
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器械摘要
Pitch PaSoft Tissue Reinforcement Device is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K230671. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pitch PaSoft Tissue Reinforcement Device?
Pitch PaSoft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Xiros, Ltd.. The 510(k) number is K230671.
When did Pitch PaSoft Tissue Reinforcement Device receive FDA 510(k) clearance?
Pitch PaSoft Tissue Reinforcement Device received FDA 510(k) clearance on 2023-05-31, under 510(k) number K230671.
Who is the listed applicant for Pitch PaSoft Tissue Reinforcement Device?
The FDA 510(k) record lists Xiros, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pitch PaSoft Tissue Reinforcement Device?
The FDA product code for Pitch PaSoft Tissue Reinforcement Device is FTL.
相关临床试验
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列明Xiros, Ltd.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：FTL）
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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