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FDA 510(k)

CuRAS hybrid

K-Number: K253123 · 2025-11-20

ApplicantClassys, Inc.
Decision Date2025-11-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CuRAS hybrid is the device name listed in this FDA 510(k) record. The listed applicant is Classys, Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K253123. 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 CuRAS hybrid?

CuRAS hybrid is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Classys, Inc.. The 510(k) number is K253123.

When did CuRAS hybrid receive FDA 510(k) clearance?

CuRAS hybrid received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253123.

Who is the listed applicant for CuRAS hybrid?

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

What is the FDA product code for CuRAS hybrid?

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

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Official Source

View on FDA Database →

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