PICO SHINING (PICO-K; PICOFY)
K-Number: K261214 · 2026-05-11
ApplicantSpeclipse, Inc.
Decision Date2026-05-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PICO SHINING (PICO-K; PICOFY) is a medical device manufactured by Speclipse, Inc.. It received FDA 510(k) clearance on 2026-05-11 under approval 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.
Frequently Asked Questions
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. It is manufactured by Speclipse, Inc.. The 510(k) number is K261214.
When was PICO SHINING (PICO-K; PICOFY) approved by the FDA?
PICO SHINING (PICO-K; PICOFY) received FDA 510(k) clearance on 2026-05-11, under approval number K261214.
What company makes PICO SHINING (PICO-K; PICOFY)?
PICO SHINING (PICO-K; PICOFY) is manufactured by Speclipse, Inc..
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.