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FDA 510(k)

VEGA

K-Number: K242859 · 2025-09-19

ApplicantIbramed Equipamentos Médicos
Decision Date2025-09-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VEGA is the device name listed in this FDA 510(k) record. The listed applicant is Ibramed Equipamentos Médicos. It received FDA 510(k) clearance on 2025-09-19 under 510(k) 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. The listed applicant is Ibramed Equipamentos Médicos. The 510(k) number is K242859.

When did VEGA receive FDA 510(k) clearance?

VEGA received FDA 510(k) clearance on 2025-09-19, under 510(k) number K242859.

Who is the listed applicant for VEGA?

The FDA 510(k) record lists Ibramed Equipamentos Médicos as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VEGA?

The FDA product code for VEGA is GEX. This falls under the Gastroenterology category.

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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