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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2025-12-03 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K250725.

When did Hugo™ RAS System receive FDA 510(k) clearance?

Hugo™ RAS System received FDA 510(k) clearance on 2025-12-03, under 510(k) number K250725.

Who is the listed applicant for Hugo™ RAS System?

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

What is the FDA product code for Hugo™ RAS System?

The FDA product code for Hugo™ RAS System is SCV.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Covidien, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: SCV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.