Hugo RAS System

Q: When was Hugo RAS System cleared by the FDA?

Hugo RAS System (K250725) received a 510(k) decision of Substantially Equivalent on December 3, 2025, 268 days after the submission was received.

Q: What is the product code of K250725?

The FDA product code is SCV – Modular Electromechanical Surgical System, a Class II (moderate risk) device regulated under 21 CFR 878.4964.

FDA 510(k) K250725 · Covidien, LLC

Substantially Equivalent

510(k) numberK250725

Submission

Device name: Hugo RAS System
Applicant: Covidien, LLC
North Haven, CT, US
Received: March 10, 2025
Decision date: December 3, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: SCV – Modular Electromechanical Surgical System
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4964
Specialty: General, Plastic Surgery

A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.

Other 510(k)s with product code SCV

510(k)	Device	Applicant	Decision
K260804	Anovo Surgical System (6Ne)SCV · Traditional	Momentis Surgical , Ltd.	07/22/2026SE
K252111	Versius Surgical System (Versius Plus)SCV · Traditional	Cmr Surgical Limited	12/16/2025SE

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Questions and answers

When was Hugo RAS System cleared by the FDA?

Hugo RAS System (K250725) received a 510(k) decision of Substantially Equivalent on December 3, 2025, 268 days after the submission was received.

What is the product code of K250725?

The FDA product code is SCV – Modular Electromechanical Surgical System, a Class II (moderate risk) device regulated under 21 CFR 878.4964.

Hugo RAS System