FDA 510(k)

RELIEF 肾盂支架套件；型号：RS-001 - 6 Fr x 24cm，RELIEF 肾盂支架套件；型号：RS-002 - 6 Fr x 26cm

K号: K213444 · 2022-03-17

决定日期2022-03-17

产品代码FAD

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决定实质等同

器械摘要

RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm is the device name listed in this FDA 510(k) record. The listed applicant is Ureteral Stent Company. It received FDA 510(k) clearance on 2022-03-17 under 510(k) number K213444. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm?

RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm is a medical device that received FDA 510(k) clearance on 2022-03-17. The listed applicant is Ureteral Stent Company. The 510(k) number is K213444.

When did RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm receive FDA 510(k) clearance?

RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm received FDA 510(k) clearance on 2022-03-17, under 510(k) number K213444.

Who is the listed applicant for RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm?

The FDA 510(k) record lists Ureteral Stent Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm?

The FDA product code for RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm is FAD.

列明Ureteral Stent Company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。

K232920RELIEF™ 肾盂支架套件；型号：RS-001 - 6 Fr x 24cm，RELIEF™ 肾盂支架套件；型号：RS-002 - 6 Fr x 26cm

相关器械（代码：FAD）

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。

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官方来源

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