灭菌袋/卷
K号: K251347 · 2026-01-28
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决定日期2026-01-28
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
Sterilization Pouch/Roll is the device name listed in this FDA 510(k) record. The listed applicant is Sterivic Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K251347. 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 Sterilization Pouch/Roll?
Sterilization Pouch/Roll is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Sterivic Medical Co., Ltd.. The 510(k) number is K251347.
When did Sterilization Pouch/Roll receive FDA 510(k) clearance?
Sterilization Pouch/Roll received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251347.
Who is the listed applicant for Sterilization Pouch/Roll?
The FDA 510(k) record lists Sterivic Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterilization Pouch/Roll?
The FDA product code for Sterilization Pouch/Roll 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。
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, LLCK253454HALYARD* 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O&M Halyard, Inc.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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