FDA 510(k)

一次性双作用组织夹

K号: K212748 · 2022-01-20

决定日期2022-01-20

产品代码PKL

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决定实质等同

器械摘要

Disposable Dual Action Tissue Clip 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 2022-01-20 under 510(k) number K212748. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Dual Action Tissue Clip?

Disposable Dual Action Tissue Clip is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K212748.

When did Disposable Dual Action Tissue Clip receive FDA 510(k) clearance?

Disposable Dual Action Tissue Clip received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212748.

Who is the listed applicant for Disposable Dual Action Tissue Clip?

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 Disposable Dual Action Tissue Clip?

The FDA product code for Disposable Dual Action Tissue Clip is PKL.

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：PKL）

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。

K253481结肠FTRD套件（200.70）；诊断FTRD套件（200.76）；胃十二指肠FTRD套件（200.72）Ovesco Endoscopy AG K254069血液夹（511系列，543系列）Hangzhou AGS MedTech Co., Ltd.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）Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus 钳Taurus Endoscopy K251562OTSCneo 系统套装 (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG

官方来源

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