Ultramatrix EUS球囊
K号: K180731 · 2018-04-19
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决定日期2018-04-19
产品代码ODG
咨询委员会GU
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器械摘要
Ultramatrix EUS Balloon is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc. (Us Endoscopy). It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K180731. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ultramatrix EUS Balloon?
Ultramatrix EUS Balloon is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is United States Endoscopy Group, Inc. (Us Endoscopy). The 510(k) number is K180731.
When did Ultramatrix EUS Balloon receive FDA 510(k) clearance?
Ultramatrix EUS Balloon received FDA 510(k) clearance on 2018-04-19, under 510(k) number K180731.
Who is the listed applicant for Ultramatrix EUS Balloon?
The FDA 510(k) record lists United States Endoscopy Group, Inc. (Us Endoscopy) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ultramatrix EUS Balloon?
The FDA product code for Ultramatrix EUS Balloon is ODG.
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：ODG）
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。
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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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