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FDA 510(k)

SUPER VELOCE

K-Number: K241699 · 2024-08-13

ApplicantIlooda Co,., Ltd.
Decision Date2024-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPER VELOCE is the device name listed in this FDA 510(k) record. The listed applicant is Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241699. 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 SUPER VELOCE?

SUPER VELOCE is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Ilooda Co,., Ltd.. The 510(k) number is K241699.

When did SUPER VELOCE receive FDA 510(k) clearance?

SUPER VELOCE received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241699.

Who is the listed applicant for SUPER VELOCE?

The FDA 510(k) record lists Ilooda Co,., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPER VELOCE?

The FDA product code for SUPER VELOCE 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.

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