穿孔篮
K号: K231291 · 2024-06-03
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决定日期2024-06-03
产品代码KCT
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Perforated Baskets is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2024-06-03 under 510(k) number K231291. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Perforated Baskets?
Perforated Baskets is a medical device that received FDA 510(k) clearance on 2024-06-03. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K231291.
When did Perforated Baskets receive FDA 510(k) clearance?
Perforated Baskets received FDA 510(k) clearance on 2024-06-03, under 510(k) number K231291.
Who is the listed applicant for Perforated Baskets?
The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Perforated Baskets?
The FDA product code for Perforated Baskets is KCT.
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Richard Wolf Medical Instruments Corporation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。
K230194HF 手术发生器 400KHZK212808Logic Hd相机头绿色，系统绿色K211332D相机控制器K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MMK201897Sensor-Ureterorenoscope 9 FR WL 600 MM (短RIWO D-URS), 控制器适配器 5525K200617Logic HD相机控制器，Logic HD Lite相机控制器，Logic 4K相机控制器，控制器5525适配器
相关器械（代码：KCT）
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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