免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

外套管（TR-1208A）；外套管（TR-1504A）；外套管（TR-1507A）

K号: K230752 · 2023-09-15

申请人FUJIFILM Healthcare Americas Corporation
决定日期2023-09-15
产品代码FED
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

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K230752. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K230752.

When did Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) receive FDA 510(k) clearance?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) received FDA 510(k) clearance on 2023-09-15, under 510(k) number K230752.

Who is the listed applicant for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

The FDA product code for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is FED.

列明FUJIFILM Healthcare Americas 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。

K261713Synapse PACS (7.6.0)K251204富士胶片加固钢丝装置（SW-2000）K243647Synapse PACS (7.5)K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CK233629APERTO 明亮 MRI 系统K233687ECHELON 协同 V10.0

查看所有 13 个设备 →

相关器械（代码：FED）

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。

K260512一次性输尿管通道鞘Yangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder 内窥镜外管Neptune Medical, Inc.K260410单次使用输尿管通道鞘Zhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex 肾盂输尿管通路鞘套装Boston Scientific CorporationK260965CVAC吸引系统Calyxo, Inc.K260521ClearEVAC输尿管吸引接入鞘（PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250）Zhuhai Pusen Medical Technology Co., Ltd.

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。

↑