Bi-Blade 视网膜切除术刀
K号: K153168 · 2016-04-29
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决定日期2016-04-29
产品代码HQE
咨询委员会OP
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决定实质等同
器械摘要
Bi-Blade Vitrectomy Cutter is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrument Development Laboratories. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K153168. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bi-Blade Vitrectomy Cutter?
Bi-Blade Vitrectomy Cutter is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Medical Instrument Development Laboratories. The 510(k) number is K153168.
When did Bi-Blade Vitrectomy Cutter receive FDA 510(k) clearance?
Bi-Blade Vitrectomy Cutter received FDA 510(k) clearance on 2016-04-29, under 510(k) number K153168.
Who is the listed applicant for Bi-Blade Vitrectomy Cutter?
The FDA 510(k) record lists Medical Instrument Development Laboratories as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bi-Blade Vitrectomy Cutter?
The FDA product code for Bi-Blade Vitrectomy Cutter is HQE.
相关临床试验
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相关器械（代码：HQE）
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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