FDA 510(k)

Wellead 内窥镜密封装置

K号: K211814 · 2022-01-14

决定日期2022-01-14

产品代码ODC

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决定实质等同

器械摘要

Wellead Endoscopic Seal is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K211814. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wellead Endoscopic Seal?

Wellead Endoscopic Seal is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K211814.

When did Wellead Endoscopic Seal receive FDA 510(k) clearance?

Wellead Endoscopic Seal received FDA 510(k) clearance on 2022-01-14, under 510(k) number K211814.

Who is the listed applicant for Wellead Endoscopic Seal?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wellead Endoscopic Seal?

The FDA product code for Wellead Endoscopic Seal is ODC.

列明Well Lead Medical 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。

K241734Wellead®亲水性间歇导尿管即用型；Wellead®亲水性间歇导尿管紧凑型 K220722PVC 亲水性尿道导管 K220036Wellead 肾盂导管 K211543魏鼻喷管 K202134Well Lead All 硅胶 Foley 导尿管带温度传感器 K203119ClearPetra 吸引-排空套管

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官方来源

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