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FDA 510(k)

Veincare

K-Number: K241930 · 2024-11-14

Decision Date2024-11-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Veincare is the device name listed in this FDA 510(k) record. The listed applicant is Wontech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K241930. 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 Veincare?

Veincare is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K241930.

When did Veincare receive FDA 510(k) clearance?

Veincare received FDA 510(k) clearance on 2024-11-14, under 510(k) number K241930.

Who is the listed applicant for Veincare?

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

What is the FDA product code for Veincare?

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

Other records listing Wontech Co., Ltd. as applicant

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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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.

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.