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FDA 510(k)

Milex™ 尿失禁碗狀栓劑；Milex™ 尿失禁碗狀栓劑附支撐；Milex™ 立方栓劑；Milex™ 立方栓劑附排液孔

K 號：K253698 · 2026-01-20

申請人Cooper Surgical
決定日期2026-01-20
產品代碼HHW
諮詢委員會OB設備之醫療設備規範文本翻譯如下： 關於OB設備的醫療設備規範文件： 此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址： 識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1
決定相當於

器材摘要

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Surgical. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K253698. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes?

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Cooper Surgical. The 510(k) number is K253698.

When did Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes receive FDA 510(k) clearance?

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253698.

Who is the listed applicant for Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes?

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

What is the FDA product code for Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes?

The FDA product code for Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes is HHW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：HHW）

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。

K250438CooperSurgical 米萊克斯® 子宮托CooperSurgical, Inc.K240798Cntrl+ 膀胱支撐式避孕環Cntrl+, Inc.K232677Reia 子宮避孕器Reia, LLCK232525Yoni.Fit 膀胱支撐器Watkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.K231786Gynethotics™ 子宮托Cosm Medical

官方來源

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