高级组织切除设备
K号: K251692 · 2026-02-21
广告
决定日期2026-02-21
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
Advanced Tissue Resection Device is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-02-21 under 510(k) number K251692. 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 Advanced Tissue Resection Device?
Advanced Tissue Resection Device is a medical device that received FDA 510(k) clearance on 2026-02-21. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K251692.
When did Advanced Tissue Resection Device receive FDA 510(k) clearance?
Advanced Tissue Resection Device received FDA 510(k) clearance on 2026-02-21, under 510(k) number K251692.
Who is the listed applicant for Advanced Tissue Resection Device?
The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Advanced Tissue Resection Device?
The FDA product code for Advanced Tissue Resection Device 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Micro-Tech (Nanjing) 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。
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.K212860SmartBand EMR 套件 (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR 包装 (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR 六角套索 (SS-230-1 或套装中)STERIS Corporation
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