Enseal X1 Large Jaw Tissue Sealer
K号: K160554 · 2016-09-09
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器械摘要
Enseal X1 Large Jaw Tissue Sealer is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K160554. 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 Enseal X1 Large Jaw Tissue Sealer?
Enseal X1 Large Jaw Tissue Sealer is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K160554.
When did Enseal X1 Large Jaw Tissue Sealer receive FDA 510(k) clearance?
Enseal X1 Large Jaw Tissue Sealer received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160554.
Who is the listed applicant for Enseal X1 Large Jaw Tissue Sealer?
The FDA 510(k) record lists Ethicon Endo-Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Enseal X1 Large Jaw Tissue Sealer?
The FDA product code for Enseal X1 Large Jaw Tissue Sealer is GEI.
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列明Ethicon Endo-Surgery, LLC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。
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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
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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