OviTex PRS (长期可吸收)
K号: K214070 · 2023-03-21
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器械摘要
OviTex PRS (Long Term Resorbable) is the device name listed in this FDA 510(k) record. The listed applicant is Tela Bio. It received FDA 510(k) clearance on 2023-03-21 under 510(k) number K214070. 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 OviTex PRS (Long Term Resorbable)?
OviTex PRS (Long Term Resorbable) is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Tela Bio. The 510(k) number is K214070.
When did OviTex PRS (Long Term Resorbable) receive FDA 510(k) clearance?
OviTex PRS (Long Term Resorbable) received FDA 510(k) clearance on 2023-03-21, under 510(k) number K214070.
Who is the listed applicant for OviTex PRS (Long Term Resorbable)?
The FDA 510(k) record lists Tela Bio as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OviTex PRS (Long Term Resorbable)?
The FDA product code for OviTex PRS (Long Term Resorbable) is FTM.
相关临床试验
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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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