FDA 510(k)

Kerecis SecureMesh

K号: K153364 · 2016-08-19

决定日期2016-08-19

产品代码OXE

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决定实质等同

器械摘要

Kerecis SecureMesh is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K153364. The device is classified under product code OXE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Kerecis SecureMesh?

Kerecis SecureMesh is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Kerecis Limited. The 510(k) number is K153364.

When did Kerecis SecureMesh receive FDA 510(k) clearance?

Kerecis SecureMesh received FDA 510(k) clearance on 2016-08-19, under 510(k) number K153364.

Who is the listed applicant for Kerecis SecureMesh?

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

What is the FDA product code for Kerecis SecureMesh?

The FDA product code for Kerecis SecureMesh is OXE.

列明Kerecis Limited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。

K251845Marigen Wound Extra; Kerecis 硅胶; Kerecis Parvus K251844Kerecis SurgiBind (50241)K243843Tendon Protect (50242)K241080Kerecis Parvus (50207)K213231Kerecis 硅胶 K202430Kerecis 重建

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官方来源

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