POWERSEAL 弯嘴封口器和分隔器，双动作
K号: K212643 · 2021-09-27
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决定日期2021-09-27
产品代码GEI
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
POWERSEAL Curved Jaw Sealer and Divider, Double Action is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2021-09-27 under 510(k) number K212643. 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 POWERSEAL Curved Jaw Sealer and Divider, Double Action?
POWERSEAL Curved Jaw Sealer and Divider, Double Action is a medical device that received FDA 510(k) clearance on 2021-09-27. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K212643.
When did POWERSEAL Curved Jaw Sealer and Divider, Double Action receive FDA 510(k) clearance?
POWERSEAL Curved Jaw Sealer and Divider, Double Action received FDA 510(k) clearance on 2021-09-27, under 510(k) number K212643.
Who is the listed applicant for POWERSEAL Curved Jaw Sealer and Divider, Double Action?
FDA 510(k)记录显示Olympus Surgical Technologies America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 POWERSEAL Curved Jaw Sealer and Divider, Double Action?
The FDA product code for POWERSEAL Curved Jaw Sealer and Divider, Double Action 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Olympus Surgical Technologies America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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