FDA 510(k)

富士胶片内窥镜型号ED-S100TP; 富士胶片内窥镜型号ED-S100XP; 富士胶片处理器型号VS-1000

K号: K251861 · 2026-03-09

决定日期2026-03-09

产品代码FDT

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决定实质等同

器械摘要

FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K251861. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000?

FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is Fujifilm Corporation. The 510(k) number is K251861.

When did FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 receive FDA 510(k) clearance?

FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 received FDA 510(k) clearance on 2026-03-09, under 510(k) number K251861.

Who is the listed applicant for FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000?

FDA 510(k)记录中列出富士胶片公司为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000?

The FDA product code for FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 is FDT.

列明Fujifilm 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。

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相关器械（代码：FDT）

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。

K253646一次性远端盖 MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III 十二指肠镜 OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III十二指肠内窥镜Olympus TJF-Q190V（TJF-Q190V）Olympus Medical Systems Corp.K233942PENTAX 医疗视频十二指肠镜 (ED34-i10T2s)；PENTAX 医疗视频处理器 (EPK-i8020c)；PENTAX 医疗一次性，无菌远端帽带提升器 (OE-A63)；气/水供应阀门 (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S K220587Evis Exera III十二指肠内窥镜Olympus TJF-Q190VOlympus Medical Systems Corp.

官方来源

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