FDA 510(k)

XNY一次性胃腔校准管

K号: K250389 · 2025-04-10

申请人Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

决定日期2025-04-10

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

XNY Disposable Gastric Calibration Tube is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250389. 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 XNY Disposable Gastric Calibration Tube?

XNY Disposable Gastric Calibration Tube is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The 510(k) number is K250389.

When did XNY Disposable Gastric Calibration Tube receive FDA 510(k) clearance?

XNY Disposable Gastric Calibration Tube received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250389.

Who is the listed applicant for XNY Disposable Gastric Calibration Tube?

The FDA 510(k) record lists Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XNY Disposable Gastric Calibration Tube?

The FDA product code for XNY Disposable Gastric Calibration Tube is KNT.

列明Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd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。

K190029一次性无刀片套管，一次性光学套管，一次性钝头套管，一次性螺旋套管，一次性刀片套管 K161905一次性痔疮圆形吻合器，一次性圆形吻合器，一次性线性吻合器，一次性内镜线性切割吻合器及弹匣，一次性线性切割吻合器及吻合器弹匣

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, LLC K253514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.K243228Flexi-Seal AIR（带 ENFit 连接器）Convatec K242336hygh-tec 排液IIAmb Medtec K242901ZZIREN™ 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 K241169Entarik 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。