FDA 510(k)

聚乙烯；聚乙烯融合；聚乙烯OrthoTape™

K号: K260775 · 2026-05-06

决定日期2026-05-06

产品代码GAT

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决定实质等同

器械摘要

Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical, LLC. It received FDA 510(k) clearance on 2026-05-06 under 510(k) number K260775. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™?

Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ is a medical device that received FDA 510(k) clearance on 2026-05-06. The listed applicant is Teleflex Medical, LLC. The 510(k) number is K260775.

When did Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ receive FDA 510(k) clearance?

Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ received FDA 510(k) clearance on 2026-05-06, under 510(k) number K260775.

Who is the listed applicant for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™?

The FDA 510(k) record lists Teleflex Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™?

The FDA product code for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ is GAT.

列明Teleflex Medical, LLC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。

K261988Monodek® (POLYDIOXANONE) 染成紫罗兰色的单丝合成可吸收外科缝合线

官方来源

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