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FDA 510(k)

HALYARD* ONE-STEP* 消毒包裹；HALYARD* QUICK CHECK* 消毒包裹；HALYARD* SEQUENTIAL 消毒包裹；HALYARD* SMART-FOLD* 消毒包裹

K号: K253454 · 2026-05-18

申请人O&M Halyard, Inc.
决定日期2026-05-18
产品代码FRG
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K253454. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap?

HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K253454.

When did HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap receive FDA 510(k) clearance?

HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap received FDA 510(k) clearance on 2026-05-18, under 510(k) number K253454.

Who is the listed applicant for HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap?

FDA 510(k)记录中列出O&M Halyard, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap?

The FDA product code for HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap is FRG.

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O&M Halyard, Inc.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。

K262014PUREZERO* MARIN* 硅橡胶无粉检查手套；PUREZERO* MARIN-XTRA* 硅橡胶无粉检查手套K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜K252941HALYARD* 成人面部口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带K243604Halyard紫色丁腈-XTRA*无粉手套，低皮炎潜力，用于化疗药物，芬太尼盐酸盐和模拟胃酸中的芬太尼盐酸盐K243172Halyard紫色丁腈*无粉手套，无菌套装；Halyard紫色丁腈*无粉手套，无菌单只

查看所有 26 个设备 →

相关器械（代码：FRG）

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。

K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术O&M Halyard, Inc.K252823Dukal 烫金纸灭菌包装Dukal, LLCK251347灭菌袋/卷Sterivic Medical Co., Ltd.K251177自封灭菌袋和卷材Guangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.K243179灭菌袋和卷Yichang Xinxin Paper Products Co., Ltd.

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。

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