FDA 510(k)

HS 光纤缝合线

K号: K231163 · 2024-01-05

决定日期2024-01-05

产品代码GAT

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决定实质等同

器械摘要

HS Fiber Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical. It received FDA 510(k) clearance on 2024-01-05 under 510(k) number K231163. 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 HS Fiber Sutures?

HS Fiber Sutures is a medical device that received FDA 510(k) clearance on 2024-01-05. The listed applicant is Riverpoint Medical. The 510(k) number is K231163.

When did HS Fiber Sutures receive FDA 510(k) clearance?

HS Fiber Sutures received FDA 510(k) clearance on 2024-01-05, under 510(k) number K231163.

Who is the listed applicant for HS Fiber Sutures?

FDA 510(k)记录显示Riverpoint Medical为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for HS Fiber Sutures?

The FDA product code for HS Fiber Sutures is GAT.

列明Riverpoint Medical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。

K262677Iconix 无结标志 K253024ProZip无结植入物 K252201HS 光纤 K252144Iconix速度锚；Iconix速度HA+锚 K243323Iconix无结锚 K243203OC JuggerKnotless 软锚；OC JuggerLoop 软锚

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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。