FDA 510(k)

ORTIV (ORTIV-BL, ORTIV-WH)

K-Number: K241646 · 2024-11-01

Decision Date2024-11-01

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORTIV (ORTIV-BL, ORTIV-WH) is a medical device manufactured by Mvitro Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under approval number K241646. 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 ORTIV (ORTIV-BL, ORTIV-WH)?

ORTIV (ORTIV-BL, ORTIV-WH) is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Mvitro Co., Ltd.. The 510(k) number is K241646.

When was ORTIV (ORTIV-BL, ORTIV-WH) approved by the FDA?

ORTIV (ORTIV-BL, ORTIV-WH) received FDA 510(k) clearance on 2024-11-01, under approval number K241646.

What company makes ORTIV (ORTIV-BL, ORTIV-WH)?

ORTIV (ORTIV-BL, ORTIV-WH) is manufactured by Mvitro Co., Ltd..

What is the FDA product code for ORTIV (ORTIV-BL, ORTIV-WH)?

The FDA product code for ORTIV (ORTIV-BL, ORTIV-WH) is GEX. This falls under the Gastroenterology category.

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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.