FDA 510(k)

OviTex PRS (长期可吸收)

K号: K243595 · 2024-12-19

决定日期2024-12-19

产品代码FTM

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

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, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K243595. 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 2024-12-19. The listed applicant is TELA Bio, Inc.. The 510(k) number is K243595.

When did OviTex PRS (Long-Term Resorbable) receive FDA 510(k) clearance?

OviTex PRS (Long-Term Resorbable) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243595.

Who is the listed applicant for OviTex PRS (Long-Term Resorbable)?

The FDA 510(k) record lists TELA Bio, Inc. 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.

列明TELA Bio, Inc.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。

K241126OviTex PRS

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。