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FDA 510(k)

VANISH PRO

K-Number: K253765 · 2026-04-22

ApplicantDdc Technologies, Inc.
Decision Date2026-04-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VANISH PRO is the device name listed in this FDA 510(k) record. The listed applicant is Ddc Technologies, Inc.. It received FDA 510(k) clearance on 2026-04-22 under 510(k) 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. The listed applicant is Ddc Technologies, Inc.. The 510(k) number is K253765.

When did VANISH PRO receive FDA 510(k) clearance?

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

Who is the listed applicant for VANISH PRO?

The FDA 510(k) record lists Ddc Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VANISH PRO?

The FDA product code for VANISH PRO 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.

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