免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Sleeved IC 2 家庭版；Sleeved IC 2 SWT（名称未最终确定）；Sleeved IC 2 Plus（名称未最终确定）；Sleeved IC 2 Pocket（名称未最终确定）；Sleeved IC 2 Plus Pocket（名称未最终确定）

K号: K233524 · 2024-05-03

申请人Hollister Incorporated
决定日期2024-05-03
产品代码EZD
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

Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K233524. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)?

Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Hollister Incorporated. The 510(k) number is K233524.

When did Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) receive FDA 510(k) clearance?

Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) received FDA 510(k) clearance on 2024-05-03, under 510(k) number K233524.

Who is the listed applicant for Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)?

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 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)?

The FDA product code for Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) is EZD.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Hollister Incorporated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。

K253295Coude袖套IC；Coude Plus袖套ICK251468Sleeved IC 3 家庭版 Sleeved IC 3 SWT（名称未最终确定） Sleeved IC 3 Pocket（名称未最终确定） Sleeved IC 3 Plus（名称未最终确定） Sleeved IC 3 Plus Pocket（名称未最终确定） (N/A)K220667Sleeved ICK213575女性IC（未最终确定）K211436间歇性导尿管（未最终确定）K193148VaPro Plus Pocket，VaPro Plus

查看所有 11 个设备 →

相关器械（代码：EZD）

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。

K261418Liquick X-treme，Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ 即用型亲水性间歇导尿管女性用（CH06 - CH16）；Cure Aqua™ 即用型亲水性间歇导尿管男性直型（CH06 - CH18）；Cure Aqua™ 即用型亲水性间歇导尿管男性弯型（CH10 - CH18）。ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja软性产品Coloplast A.S.K260394一次性使用亲水性涂层间歇性纳拉通导尿管（NCR）Hangzhou Jimushi Meditech Co., Ltd.K253295Coude袖套IC；Coude Plus袖套ICHollister Incorporated

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。

↑