ViSiGi 3D 胃部测量导管
K号: K234145 · 2024-01-26
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决定日期2024-01-26
产品代码KNT
咨询委员会GU
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决定实质等同
器械摘要
ViSiGi 3D Gastric Sizing Tube is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K234145. 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 ViSiGi 3D Gastric Sizing Tube?
ViSiGi 3D Gastric Sizing Tube is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Boehringer Laboratories. The 510(k) number is K234145.
When did ViSiGi 3D Gastric Sizing Tube receive FDA 510(k) clearance?
ViSiGi 3D Gastric Sizing Tube received FDA 510(k) clearance on 2024-01-26, under 510(k) number K234145.
Who is the listed applicant for ViSiGi 3D Gastric Sizing Tube?
The FDA 510(k) record lists Boehringer Laboratories as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ViSiGi 3D Gastric Sizing Tube?
The FDA product code for ViSiGi 3D Gastric Sizing Tube 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）ConvatecK242336hygh-tec 排液IIAmb MedtecK242901ZZIREN™ 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, LLC
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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