PICO SHINING (PICO-K; PICOFY)
K号: K261214 · 2026-05-11
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器械摘要
PICO SHINING (PICO-K; PICOFY) is the device name listed in this FDA 510(k) record. The listed applicant is Speclipse, Inc.. It received FDA 510(k) clearance on 2026-05-11 under 510(k) number K261214. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the PICO SHINING (PICO-K; PICOFY)?
PICO SHINING (PICO-K; PICOFY) is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Speclipse, Inc.. The 510(k) number is K261214.
When did PICO SHINING (PICO-K; PICOFY) receive FDA 510(k) clearance?
PICO SHINING (PICO-K; PICOFY) received FDA 510(k) clearance on 2026-05-11, under 510(k) number K261214.
Who is the listed applicant for PICO SHINING (PICO-K; PICOFY)?
The FDA 510(k) record lists Speclipse, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PICO SHINING (PICO-K; PICOFY)?
The FDA product code for PICO SHINING (PICO-K; PICOFY) is GEX. This falls under the Gastroenterology category.
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Speclipse, 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。
相关器械（代码：GEX）
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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