BiZact 开放封合器/分隔器
K号: K160539 · 2016-06-15
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器械摘要
BiZact Open Sealer/Divider is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-06-15 under 510(k) number K160539. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BiZact Open Sealer/Divider?
BiZact Open Sealer/Divider is a medical device that received FDA 510(k) clearance on 2016-06-15. The listed applicant is Covidien. The 510(k) number is K160539.
When did BiZact Open Sealer/Divider receive FDA 510(k) clearance?
BiZact Open Sealer/Divider received FDA 510(k) clearance on 2016-06-15, under 510(k) number K160539.
Who is the listed applicant for BiZact Open Sealer/Divider?
The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BiZact Open Sealer/Divider?
The FDA product code for BiZact Open Sealer/Divider is GEI.
相关临床试验
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。
列明Covidien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。
相关器械（代码：GEI）
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
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