FDA 510(k)

RELiZORB (100300/100301)

K号: K250499 · 2025-04-17

决定日期2025-04-17

产品代码PLQ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

RELiZORB (100300/100301) is the device name listed in this FDA 510(k) record. The listed applicant is Alcresta Therapeutics, Inc.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K250499. The device is classified under product code PLQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RELiZORB (100300/100301)?

RELiZORB (100300/100301) is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Alcresta Therapeutics, Inc.. The 510(k) number is K250499.

When did RELiZORB (100300/100301) receive FDA 510(k) clearance?

RELiZORB (100300/100301) received FDA 510(k) clearance on 2025-04-17, under 510(k) number K250499.

Who is the listed applicant for RELiZORB (100300/100301)?

The FDA 510(k) record lists Alcresta Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELiZORB (100300/100301)?

The FDA product code for RELiZORB (100300/100301) is PLQ.

列明Alcresta Therapeutics, Inc.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。

K243284RELiZORB (100300/ 100301)K232784RELiZORB®K231156酶填充弹匣 - RELiZORB K191379RELiZORB K163057Relizorb K161247Relizorb

查看所有 7 个设备 →

官方来源

在 FDA 数据库中查看 →

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。