ClearGrasp Snare
K号: K183289 · 2019-03-06
广告
决定日期2019-03-06
产品代码FDI
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
ClearGrasp Snare is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2019-03-06 under 510(k) number K183289. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ClearGrasp Snare?
ClearGrasp Snare is a medical device that received FDA 510(k) clearance on 2019-03-06. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K183289.
When did ClearGrasp Snare receive FDA 510(k) clearance?
ClearGrasp Snare received FDA 510(k) clearance on 2019-03-06, under 510(k) number K183289.
Who is the listed applicant for ClearGrasp Snare?
The FDA 510(k) record lists Finemedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ClearGrasp Snare?
The FDA product code for ClearGrasp Snare is FDI.
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Finemedix Co., Ltd.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。
相关器械（代码：FDI）
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。
K251692高级组织切除设备Micro-Tech (Nanjing) Co., Ltd.K221713息肉圈套器Hangzhou AGS MedTech Co., Ltd.K220846CORE-SNAREIncore Co., Ltd.K220089一次性息肉圈套Jiangsu Vedkang Medical Science and Technology Co., Ltd.K220790一次性息肉切除术圈套，一次性息肉切除术混合圈套Yangzhou Fartley Medical Instrument Technology Co., Ltd.K213222一次性息肉切除术圈套Beijing Zksk Technology Co., Ltd.
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。
广告