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FDA 510(k)

VANISH PRO

K-Number: K253765 · 2026-04-22

Decision Date2026-04-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VANISH PRO is a medical device manufactured by Ddc Technologies, Inc.. It received FDA 510(k) clearance on 2026-04-22 under approval number K253765. 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 VANISH PRO?

VANISH PRO is a medical device that received FDA 510(k) clearance on 2026-04-22. It is manufactured by Ddc Technologies, Inc.. The 510(k) number is K253765.

When was VANISH PRO approved by the FDA?

VANISH PRO received FDA 510(k) clearance on 2026-04-22, under approval number K253765.

What company makes VANISH PRO?

VANISH PRO is manufactured by Ddc Technologies, Inc..

What is the FDA product code for VANISH PRO?

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

Related Devices (Code: GEX)

Official Source

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