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 a medical device manufactured by Classys, Inc.. It received FDA 510(k) clearance on 2025-11-20 under approval 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. It is manufactured by Classys, Inc.. The 510(k) number is K253123.
When was CuRAS hybrid approved by the FDA?
CuRAS hybrid received FDA 510(k) clearance on 2025-11-20, under approval number K253123.
What company makes CuRAS hybrid?
CuRAS hybrid is manufactured by Classys, Inc..
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 →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.