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FDA 510(k)

Entarik 鼻饲管系统；Entarik 鼻饲管

K号: K230206 · 2023-03-24

申请人Gravitas Medical, Inc.
决定日期2023-03-24
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

Entarik Feeding Tube System; Entarik Feeding Tube is the device name listed in this FDA 510(k) record. The listed applicant is Gravitas Medical, Inc.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K230206. 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 Entarik Feeding Tube System; Entarik Feeding Tube?

Entarik Feeding Tube System; Entarik Feeding Tube is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Gravitas Medical, Inc.. The 510(k) number is K230206.

When did Entarik Feeding Tube System; Entarik Feeding Tube receive FDA 510(k) clearance?

Entarik Feeding Tube System; Entarik Feeding Tube received FDA 510(k) clearance on 2023-03-24, under 510(k) number K230206.

Who is the listed applicant for Entarik Feeding Tube System; Entarik Feeding Tube?

The FDA 510(k) record lists Gravitas Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Entarik Feeding Tube System; Entarik Feeding Tube?

The FDA product code for Entarik Feeding Tube System; Entarik Feeding 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。

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Gravitas Medical, 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。

K241169Entarik NI 鼻饲管系统

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

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