FETOLY
K-Number: K251368 · 2025-09-12
ApplicantDiagnoly
Decision Date2025-09-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FETOLY is a medical device manufactured by Diagnoly. It received FDA 510(k) clearance on 2025-09-12 under approval number K251368. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FETOLY?
FETOLY is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Diagnoly. The 510(k) number is K251368.
When was FETOLY approved by the FDA?
FETOLY received FDA 510(k) clearance on 2025-09-12, under approval number K251368.
What company makes FETOLY?
FETOLY is manufactured by Diagnoly.
What is the FDA product code for FETOLY?
The FDA product code for FETOLY is IYN.
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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.