FDA 510(k)

PENTAX 医疗视频上消化道镜 (EG 系列) (EG 系列)；PENTAX 医疗视频结肠镜 (EC 系列) (EC 系列)

K号: K251256 · 2025-12-16

决定日期2025-12-16

产品代码FDS

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决定实质等同

器械摘要

PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K251256. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)?

PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Pentax of America, Inc.. The 510(k) number is K251256.

When did PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) receive FDA 510(k) clearance?

PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K251256.

Who is the listed applicant for PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)?

The FDA product code for PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) is FDS.

列明Pentax of America, Inc.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。

K251127PENTAX 医疗视频处理器 (EPK-i8020c)K242110PENTAX 医疗视频结肠镜 (EC38-i20cWL)K241213PENTAX 医疗视频上消化道镜 (EG27-i20c)；PENTAX 医疗视频结肠镜 (EC34-i20cL)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 )K240457C2 冷冻球囊消融系统（C2 冷冻球囊消融系统）K232860PENTAX 医疗视频处理器 EPK-i8020c，PENTAX 医疗视频支气管镜 EB11-J10，PENTAX 医疗视频支气管镜 EB15-J10，PENTAX 医疗视频支气管镜 EB19-J10U，PENTAX 医疗超声视频支气管镜 EB19-J10U

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