FDA 510(k)

充氣保留裝置 (IRD) (11173-325-101)

K 號：K261587 · 2026-07-02

決定日期2026-07-02

產品代碼FDF

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 BPEndo, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K213773充氣保留裝置

相關器械（代碼：FDF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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