FDA 510(k)

MAXReach 激光探头

K号: K191846 · 2019-12-23

决定日期2019-12-23

产品代码HQB

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决定实质等同

器械摘要

MAXReach Laser Probe is the device name listed in this FDA 510(k) record. The listed applicant is Vortex Surgical, Inc.. It received FDA 510(k) clearance on 2019-12-23 under 510(k) number K191846. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MAXReach Laser Probe?

MAXReach Laser Probe is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Vortex Surgical, Inc.. The 510(k) number is K191846.

When did MAXReach Laser Probe receive FDA 510(k) clearance?

MAXReach Laser Probe received FDA 510(k) clearance on 2019-12-23, under 510(k) number K191846.

Who is the listed applicant for MAXReach Laser Probe?

The FDA 510(k) record lists Vortex Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXReach Laser Probe?

The FDA product code for MAXReach Laser Probe is HQB.

列明Vortex Surgical, Inc.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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官方来源

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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。