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FDA 510(k)

Lap-Band 系统校准管

K号: K220455 · 2022-06-07

申请人Reshape Lifesciences
决定日期2022-06-07
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

Lap-Band System Calibration Tube is the device name listed in this FDA 510(k) record. The listed applicant is Reshape Lifesciences. It received FDA 510(k) clearance on 2022-06-07 under 510(k) number K220455. 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 Lap-Band System Calibration Tube?

Lap-Band System Calibration Tube is a medical device that received FDA 510(k) clearance on 2022-06-07. The listed applicant is Reshape Lifesciences. The 510(k) number is K220455.

When did Lap-Band System Calibration Tube receive FDA 510(k) clearance?

Lap-Band System Calibration Tube received FDA 510(k) clearance on 2022-06-07, under 510(k) number K220455.

Who is the listed applicant for Lap-Band System Calibration Tube?

The FDA 510(k) record lists Reshape Lifesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lap-Band System Calibration Tube?

The FDA product code for Lap-Band System Calibration 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Reshape Lifesciences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。

K241039ReShape 校准管（B-2032，B-2036，B-2040）；ReShape 校准管（B-2017）；胃球囊吸引导管（B-2020）K230131ReShape 校准管K221898胃肠道边界标识器（GIBI HD）

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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