VEGA
K-Number: K242859 · 2025-09-19
ApplicantIbramed Equipamentos Médicos
Decision Date2025-09-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
VEGA is a medical device manufactured by Ibramed Equipamentos Médicos. It received FDA 510(k) clearance on 2025-09-19 under approval number K242859. 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 VEGA?
VEGA is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Ibramed Equipamentos Médicos. The 510(k) number is K242859.
When was VEGA approved by the FDA?
VEGA received FDA 510(k) clearance on 2025-09-19, under approval number K242859.
What company makes VEGA?
VEGA is manufactured by Ibramed Equipamentos Médicos.
What is the FDA product code for VEGA?
The FDA product code for VEGA 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.