DuraFuse夹和施用系统
K号: K213813 · 2022-07-22
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器械摘要
DuraFuse Clip and Applier System is the device name listed in this FDA 510(k) record. The listed applicant is Neuramedica, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K213813. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DuraFuse Clip and Applier System?
DuraFuse Clip and Applier System is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Neuramedica, Inc.. The 510(k) number is K213813.
When did DuraFuse Clip and Applier System receive FDA 510(k) clearance?
DuraFuse Clip and Applier System received FDA 510(k) clearance on 2022-07-22, under 510(k) number K213813.
Who is the listed applicant for DuraFuse Clip and Applier System?
The FDA 510(k) record lists Neuramedica, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DuraFuse Clip and Applier System?
The FDA product code for DuraFuse Clip and Applier System is FZP.
相关临床试验
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相关器械（代码：FZP）
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。
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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。
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