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FDA 510(k)

袖套式IC 3 系列袖套式IC 3 SWT（名稱尚未確定）袖套式IC 3 領口（名稱尚未確定）袖套式IC 3 Plus（名稱尚未確定）袖套式IC 3 Plus 領口（名稱尚未確定）（N/A）

K 號：K251468 · 2025-10-03

申請人Hollister Incorporated
決定日期2025-10-03
產品代碼EZD
諮詢委員會GU
決定相當於

器材摘要

Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K251468. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)?

Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Hollister Incorporated. The 510(k) number is K251468.

When did Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) receive FDA 510(k) clearance?

Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K251468.

Who is the listed applicant for Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)?

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

What is the FDA product code for Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)?

The FDA product code for Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) is EZD.

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

其他以 Hollister Incorporated 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。

K253295曲管套筒內芯IC；曲管加套筒內芯ICK233524袖套式IC 2 系列產品；袖套式IC 2 SWT（名稱尚未確定）；袖套式IC 2 Plus（名稱尚未確定）；袖套式IC 2 頰袋（名稱尚未確定）；袖套式IC 2 Plus 頰袋（名稱尚未確定）K220667袖套式ICK213575女性IC（未定案）K211436間斷導尿管（未定案）K193148VaPro Plus 頸帶式，VaPro Plus

查看所有 11 項裝置 →

相關器械（代碼：EZD）

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。

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ 即用型親水性間歇性導尿管女性用 (CH06 - CH16)；Cure Aqua™ 即用型親水性間歇性導尿管男性直型 (CH06 - CH18)；Cure Aqua™ 即用型親水性間歇性導尿管男性彎型 (CH10 - CH18)。ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045盧加軟件Coloplast A.S.K260394親水性塗層單次使用間歇性奈頓導尿管（NCR）Hangzhou Jimushi Meditech Co., Ltd.K253295曲管套筒內芯IC；曲管加套筒內芯ICHollister Incorporated

官方來源

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