hygh-tec 排液II
K号: K242336 · 2025-01-17
广告
申请人Amb Medtec
决定日期2025-01-17
产品代码KNT
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
hygh-tec Drainage II is the device name listed in this FDA 510(k) record. The listed applicant is Amb Medtec. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242336. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the hygh-tec Drainage II?
hygh-tec Drainage II is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Amb Medtec. The 510(k) number is K242336.
When did hygh-tec Drainage II receive FDA 510(k) clearance?
hygh-tec Drainage II received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242336.
Who is the listed applicant for hygh-tec Drainage II?
The FDA 510(k) record lists Amb Medtec as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for hygh-tec Drainage II?
The FDA product code for hygh-tec Drainage II is KNT.
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：KNT）
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。
K26189052Fr ViSiGi LUX™；52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514明尼苏达四腔食管胃填塞管 - 18 French (0092220)；布莱克莫尔食管鼻胃管 - 20 French (0092100)；布莱克莫尔食管鼻胃管 - 16 French (0092300)C.R. Bard, Inc.K250389XNY一次性胃腔校准管Changzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR（带 ENFit 连接器）ConvatecK242901ZZIREN™ 口胃管；ZZIREN™ SGT 口胃管 - 32 Fr（ZZ-SGT-32）；ZZIREN™ SGT 口胃管 - 36 Fr（ZZ-SGT-36）；ZZIREN™ SGT 口胃管 - 40 Fr（ZZ-SGT-40）；ZZIREN™ GBT 口胃管 - 32 Fr（ZZ-GBT-32）；ZZIREN™ GBT 口胃管 - 36 Fr（ZZ-GBT-36）；ZZIREN™ GBT 口胃管 - 40 Fr（ZZ-GBT-40）Tools For Surgery, LLCK241169Entarik NI 鼻饲管系统Gravitas Medical, Inc.
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。
广告