Olo
K-Number: K251432 · 2025-08-06
ApplicantEl.En S.P.A.
Decision Date2025-08-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Olo is a medical device manufactured by El.En S.P.A.. It received FDA 510(k) clearance on 2025-08-06 under approval number K251432. 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 Olo?
Olo is a medical device that received FDA 510(k) clearance on 2025-08-06. It is manufactured by El.En S.P.A.. The 510(k) number is K251432.
When was Olo approved by the FDA?
Olo received FDA 510(k) clearance on 2025-08-06, under approval number K251432.
What company makes Olo?
Olo is manufactured by El.En S.P.A..
What is the FDA product code for Olo?
The FDA product code for Olo 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.