FDA 510(k)

Force Fiber Suture

K号: K191268 · 2019-06-11

决定日期2019-06-11

产品代码GAT

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决定实质等同

器械摘要

Force Fiber Suture is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical Incorporated. It received FDA 510(k) clearance on 2019-06-11 under 510(k) number K191268. 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 Force Fiber Suture?

Force Fiber Suture is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Teleflex Medical Incorporated. The 510(k) number is K191268.

When did Force Fiber Suture receive FDA 510(k) clearance?

Force Fiber Suture received FDA 510(k) clearance on 2019-06-11, under 510(k) number K191268.

Who is the listed applicant for Force Fiber Suture?

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

What is the FDA product code for Force Fiber Suture?

The FDA product code for Force Fiber Suture is GAT.

列明Teleflex Medical Incorporated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。

K181774Force Fiber 白色和白色/蓝色、白色/黑色、蓝色和白色/绿色缝合线；Force Fiber OrthoTape 缝合线；Bondek 缝合线和 Bondek Plus 缝合线；Monodek 缝合线；Polyglytone*6211 缝合线 K172016Force Fiber Fusion Suture

官方来源

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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。