Hugo RAS System
K-Number: K250725 · 2025-12-03
ApplicantCovidien, LLC
Decision Date2025-12-03
Product CodeSCV
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Hugo RAS System is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2025-12-03 under approval number K250725. The device is classified under product code SCV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hugo RAS System?
Hugo RAS System is a medical device that received FDA 510(k) clearance on 2025-12-03. It is manufactured by Covidien, LLC. The 510(k) number is K250725.
When was Hugo RAS System approved by the FDA?
Hugo RAS System received FDA 510(k) clearance on 2025-12-03, under approval number K250725.
What company makes Hugo RAS System?
Hugo RAS System is manufactured by Covidien, LLC.
What is the FDA product code for Hugo RAS System?
The FDA product code for Hugo RAS System is SCV.
Other Devices by Covidien, LLC
Related Devices (Code: SCV)
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.