SurgiPure XD Reconstructive Tissue Matrix
K号: K152206 · 2016-03-08
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决定日期2016-03-08
产品代码FTM
咨询委员会SU
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决定实质等同
器械摘要
SurgiPure XD Reconstructive Tissue Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regenix Group Plc. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K152206. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SurgiPure XD Reconstructive Tissue Matrix?
SurgiPure XD Reconstructive Tissue Matrix is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Tissue Regenix Group Plc. The 510(k) number is K152206.
When did SurgiPure XD Reconstructive Tissue Matrix receive FDA 510(k) clearance?
SurgiPure XD Reconstructive Tissue Matrix received FDA 510(k) clearance on 2016-03-08, under 510(k) number K152206.
Who is the listed applicant for SurgiPure XD Reconstructive Tissue Matrix?
The FDA 510(k) record lists Tissue Regenix Group Plc as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SurgiPure XD Reconstructive Tissue Matrix?
The FDA product code for SurgiPure XD Reconstructive Tissue Matrix is FTM.
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相关器械（代码：FTM）
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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