FDA.reportPublic FDA data

Hugo RAS

Primary DI
10884521850958
Brand
Hugo RAS
Company
Covidien LP
Model
MRASI0004
Device description
Bipolar Fenestrated Grasper
Published
2026-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SCVModular electromechanical surgical system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCVModular Electromechanical Surgical SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250725000Hugo™ RAS SystemCovidien, LLC2025-12-03SCV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521850958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452185095810884521850958

GMDN Terms#

Term, Definition table
TermDefinition
Robotic electrosurgical instrument, bipolar, reusableAn electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It includes a long thin body with a proximal housing intended to attach to the robotic arm, and may include the distal bipolar electrode in one of a variety of forms (e.g., forceps, hook). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-30 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Keep Dry
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521703827Tri-Staple 2.0SIGCIR21MTORVIL2026-08-09
10884521703834Tri-Staple 2.0SIGCIR21XTORVIL2026-08-09
10884521703841Tri-Staple 2.0SIGCIR25MTORVIL2026-08-09
10884521703858Tri-Staple 2.0SIGCIR25XTORVIL2026-08-09
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26

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Primary DI, Brand, Company table
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05060548210229Versius Bedside Unit Cable (Short)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210366Versius Bedside Unit Cable (Long)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210526Versius Monopolar Instrument CableCMR SURGICAL LIMITEDSCV2026-03-10
05060548210724Versius Endoscope 30° (compatible with vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210748Versius Camera Head (compatible with vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210502Versius Bipolar Instrument CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548210519Versius Bipolar Bedside Unit CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548210533Versius Monopolar Bedside Unit CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548211226Versius Surgeon ConsoleCMR SURGICAL LIMITEDSCV2026-03-09
05060548211233Versius Instrument Bedside UnitCMR SURGICAL LIMITEDSCV2026-03-09
05060548211240Versius Visualisation Bedside UnitCMR SURGICAL LIMITEDSCV2026-03-09
05060548211257Versius Needle HolderCMR SURGICAL LIMITEDSCV2026-03-09
05060548211264Versius Bipolar Maryland GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211271Versius Fenestrated GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211288Versius Monopolar HookCMR SURGICAL LIMITEDSCV2026-03-09
05060548211295Versius Curved ScissorsCMR SURGICAL LIMITEDSCV2026-03-09
05060548211301Versius Monopolar Curved ScissorsCMR SURGICAL LIMITEDSCV2026-03-09
05060548211318Versius Insulating Sleeve AccessoryCMR SURGICAL LIMITEDSCV2026-03-09
05060548211325Versius Cadiere GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211332Versius Bipolar Fenestrated GrasperCMR SURGICAL LIMITEDSCV2026-03-09
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