单次使用细针穿刺活检(FNB)装置 (NA-U210H)
K号: K252646 · 2025-10-24
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决定日期2025-10-24
产品代码FCG
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
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K252646. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K252646.
When did Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) receive FDA 510(k) clearance?
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) received FDA 510(k) clearance on 2025-10-24, under 510(k) number K252646.
Who is the listed applicant for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?
FDA 510(k)记录中列出Olympus Medical Systems Corp.为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)?
The FDA product code for Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) is FCG.
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Olympus Medical Systems Corp.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。
K2620794K摄像头头 OLYMPUS CH-S700-08-LBK254056THUNDERBEAT 5 mm, 45 cm, 前驱动握把类型S (TB-0545FCS)；THUNDERBEAT 5 mm, 35 cm, 前驱动握把类型S (TB-0535FCS)；THUNDERBEAT 5 mm, 20 cm, 前驱动握把类型S (TB-0520FCS)K260580单次使用可重装夹子应用器（HX-810LR，HX-810UR）；夹子（HX-610-090，HX-610-135）；长夹子（HX-610-090L，HX-610-135L）；短夹子（HX-610-090S，HX-610-135S）；超短夹子（HX-610-135XS）K252341EVIS EXERA III 喉镜 (OLYMPUS BF-Q190); EVIS EXERA III 喉镜 (OLYMPUS BF-H190); EVIS EXERA III 喉镜 (OLYMPUS BF-1TH190)K251807一次性电外科止血镊 FD-410LR, FD-411UR, FD-412LRK253646一次性远端盖 MAJ-2315 (MAJ-2315)
相关器械（代码：FCG）
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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