FDA 510(k)

一次性视频胰胆管镜，PB数字控制器

K号: K221784 · 2023-02-16

决定日期2023-02-16

产品代码FBN

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决定实质等同

器械摘要

Single-use Video Pancreaticobiliary Scope, PB Digital Controller 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 2023-02-16 under 510(k) number K221784. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

Single-use Video Pancreaticobiliary Scope, PB Digital Controller is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K221784.

When did Single-use Video Pancreaticobiliary Scope, PB Digital Controller receive FDA 510(k) clearance?

Single-use Video Pancreaticobiliary Scope, PB Digital Controller received FDA 510(k) clearance on 2023-02-16, under 510(k) number K221784.

Who is the listed applicant for Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

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 Single-use Video Pancreaticobiliary Scope, PB Digital Controller?

The FDA product code for Single-use Video Pancreaticobiliary Scope, PB Digital Controller is FBN.

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。

K252492可视化接入与输送导管；PB数字控制器 K251692高级组织切除设备 K250229双重作用组织闭合装置 K243388一次性远端帽 K243471提取篮 K230127胆道塑料支架，胆道塑料支架导引器，胆道塑料支架套装，胆道塑料支架导引器/短导丝兼容型，胆道塑料支架套装/短导丝兼容型

查看所有 37 个设备 →

相关器械（代码：FBN）

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。

K254153一次性视频内镜；PB数字控制器Mirco-Tech (Nanjing) Co., Ltd.K253139一次性远端帽Mirco-Tech (Nanjing) Co., Ltd.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）Scivita Medical Technology Co., Ltd.K251170Tangent 单次使用数字系统：Tangent 单次使用数字导管和 Tangent 数字控制器Tangent Endoscopy, LLC K243535柔性视频胆道镜（CHV-110J-U）；柔性视频胆道镜（CHV-US120J-U）Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444胆胰管内窥镜系统Shenzhen HugeMed Medical Technical Development Co., Ltd.

官方来源

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