FDA 510(k)

Niti-S 十二指肠支架; Niti-S 结肠舒适支架

K号: K223067 · 2023-06-14

决定日期2023-06-14

产品代码MUM

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决定实质等同

器械摘要

Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-06-14 under 510(k) number K223067. The device is classified under product code MUM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent?

Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent is a medical device that received FDA 510(k) clearance on 2023-06-14. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K223067.

When did Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent receive FDA 510(k) clearance?

Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent received FDA 510(k) clearance on 2023-06-14, under 510(k) number K223067.

Who is the listed applicant for Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent?

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

What is the FDA product code for Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent?

The FDA product code for Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent is MUM.

列明Taewoong 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。

K260962Sphincterotome K252648Niti-S SPAXUS 支架 K251123Niti-S 胆道支架; Niti-S 胆道细 M 支架 K243619Niti-S 食管支架; 食管 TTS 支架 K250663Niti-S 十二指肠舒适支架，Niti-S 结肠舒适支架 K223626Niti-S 胆道速 D 支架

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官方来源

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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。