Katalyst循环光凝探头
K号: K163632 · 2017-06-15
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决定日期2017-06-15
产品代码LQJ
咨询委员会OP
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决定实质等同
器械摘要
Katalyst Cyclophotocoagulation Probe is the device name listed in this FDA 510(k) record. The listed applicant is Katalyst Surgical, LLC. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K163632. The device is classified under product code LQJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Katalyst Cyclophotocoagulation Probe?
Katalyst Cyclophotocoagulation Probe is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Katalyst Surgical, LLC. The 510(k) number is K163632.
When did Katalyst Cyclophotocoagulation Probe receive FDA 510(k) clearance?
Katalyst Cyclophotocoagulation Probe received FDA 510(k) clearance on 2017-06-15, under 510(k) number K163632.
Who is the listed applicant for Katalyst Cyclophotocoagulation Probe?
The FDA 510(k) record lists Katalyst Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Katalyst Cyclophotocoagulation Probe?
The FDA product code for Katalyst Cyclophotocoagulation Probe is LQJ.
相关临床试验
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列明Katalyst Surgical, 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。
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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