Cleared Traditional

K250725 - Hugo™ RAS System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K250725 · Covidien, LLC · General & Plastic Surgery device
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Dec 2025
Decision
268d
Days
Class 2
Risk

K250725 is an FDA 510(k) clearance for the Hugo™ RAS System. Classified as Modular Electromechanical Surgical System (product code SCV), Class II - Special Controls.

Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on December 3, 2025 after a review of 268 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4964 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Covidien, LLC devices

Submission Details

510(k) Number K250725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2025
Decision Date December 03, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 114d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SCV Modular Electromechanical Surgical System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4964
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05696444 Active not recruiting Interventional Industry-sponsored

Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

144
Patients (actual)
6
Sites
Treatment
Purpose
Open label
Masking
Condition studied Bladder Cancer; Prostate Cancer; Kidney Cancer; Pelvic Tumor; Interstitial Cystitis; Congenital Abnormalities; End Stage Renal Disease; Renal Tumor; Kidney Injury
Study design Single group
Eligibility All sexes · 22 Years+
Principal investigator Michael Abern, MD
Sponsor Medtronic - MITG (industry)
Started 2022-12-14 → Primary completion 2024-10-10 → Completed 2030-01-31
Primary outcome
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
Secondary outcome
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
View full study on ClinicalTrials.gov