RIVOS™ EUS 访问装置 (M00553900)
K号: K260428 · 2026-06-17
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决定日期2026-06-17
产品代码ODG
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
RIVOS™ EUS Access Device (M00553900) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K260428. 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 RIVOS™ EUS Access Device (M00553900)?
RIVOS™ EUS Access Device (M00553900) is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K260428.
When did RIVOS™ EUS Access Device (M00553900) receive FDA 510(k) clearance?
RIVOS™ EUS Access Device (M00553900) received FDA 510(k) clearance on 2026-06-17, under 510(k) number K260428.
Who is the listed applicant for RIVOS™ EUS Access Device (M00553900)?
FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for RIVOS™ EUS Access Device (M00553900)?
The FDA product code for RIVOS™ EUS Access Device (M00553900) 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。
列明Boston Scientific Corporation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。
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。
K261183EVIS EUS 超声胃肠内窥镜（Olympus GF-UE190）Olympus Medical Systems CorporationK251859EVIS EUS 超声胃肠内窥镜（Olympus GF-UE190）Olympus Medical Systems CorporationK251542InstaFANOnepass Medical , Ltd.K231813超声胃镜Sonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, Inc.K223616Acquire™ S 内窥镜超声细针穿刺活检（FNB）设备Boston Scientific Corporation
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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