FDA 510(k)

一次性使用提取篮

K号: K240192 · 2024-10-15

决定日期2024-10-15

产品代码LQR

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决定实质等同

器械摘要

Single-use Extraction Baskets is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K240192. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Single-use Extraction Baskets?

Single-use Extraction Baskets is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K240192.

When did Single-use Extraction Baskets receive FDA 510(k) clearance?

Single-use Extraction Baskets received FDA 510(k) clearance on 2024-10-15, under 510(k) number K240192.

Who is the listed applicant for Single-use Extraction Baskets?

FDA 510(k)记录将斯奇维塔医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Single-use Extraction Baskets?

The FDA product code for Single-use Extraction Baskets is LQR.

列明Scivita Medical Technology 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。

K262552一次性使用柔性输尿管镜（一次性使用柔性输尿管镜：SUV-5C-B）K251338胆管镜可视化系统（一次性视频胆管镜：SCV-P-01G，SCV-P-02G；全高清可视化内镜图像处理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）K243708泌尿外科视频内镜系统（一次性使用柔性输尿管镜：SUV-1A-B，SUV-1A-P，SUV-2A-B，SUV-2A-P，SUV-2B-B，SUB-2B-P，SUV-2C-B，SUV-2C-P；一次性使用柔性膀胱镜：SUV-1D-B，SUV-1D-P；内镜图像处理器：HDVS-S100A，HDVS-S100D。）K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))K240289全高清内镜图像处理器（HDVS-S200A，HDVS-S200B，HDVS-S200C，HDVS-S200D）K231521Broncho Videoscope System

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官方来源

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