LevaLap腹腔镜通道装置
K号: K212786 · 2022-02-23
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决定日期2022-02-23
产品代码HIF
咨询委员会OB
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决定实质等同
器械摘要
LevaLap Laparoscopic Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Core Access Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K212786. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LevaLap Laparoscopic Access Device?
LevaLap Laparoscopic Access Device is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Core Access Surgical Technologies, Inc.. The 510(k) number is K212786.
When did LevaLap Laparoscopic Access Device receive FDA 510(k) clearance?
LevaLap Laparoscopic Access Device received FDA 510(k) clearance on 2022-02-23, under 510(k) number K212786.
Who is the listed applicant for LevaLap Laparoscopic Access Device?
The FDA 510(k) record lists Core Access Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LevaLap Laparoscopic Access Device?
The FDA product code for LevaLap Laparoscopic Access Device is HIF.
相关临床试验
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相关器械（代码：HIF）
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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