FDA 510(k)

充气保留装置（IRD）(11173-325-101)

K号: K261587 · 2026-07-02

决定日期2026-07-02

产品代码FDF

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决定实质等同

器械摘要

Insufflation Retention Device (IRD) (11173-325-101) is the device name listed in this FDA 510(k) record. The listed applicant is BPEndo, LLC. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K261587. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Insufflation Retention Device (IRD) (11173-325-101)?

Insufflation Retention Device (IRD) (11173-325-101) is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is BPEndo, LLC. The 510(k) number is K261587.

When did Insufflation Retention Device (IRD) (11173-325-101) receive FDA 510(k) clearance?

Insufflation Retention Device (IRD) (11173-325-101) received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261587.

Who is the listed applicant for Insufflation Retention Device (IRD) (11173-325-101)?

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

What is the FDA product code for Insufflation Retention Device (IRD) (11173-325-101)?

The FDA product code for Insufflation Retention Device (IRD) (11173-325-101) is FDF.

列明BPEndo, LLC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。

K213773充气保留装置

官方来源

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