FDA.reportPublic FDA data

Versius Bipolar Fenestrated Grasper

Primary DI
05060548211332
Brand
Versius Bipolar Fenestrated Grasper
Company
CMR SURGICAL LIMITED
Model
11220
Published
2026-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K252111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252111000Versius Surgical System (Versius Plus)Cmr Surgical Limited2025-12-16SCV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060548211332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060548211332050605482113325060548211332

GMDN Terms#

Term, Definition table
TermDefinition
Robotic endoscopic 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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
219860797
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060548211264Versius Bipolar Maryland Grasper102202026-03-09
05060548211288Versius Monopolar Hook104202026-03-09
05060548211301Versius Monopolar Curved Scissors106202026-03-09
05060548211349Versius Insulating Sleeve Accessory – Carton Pack (Qty 12 x 10021), 10022100222026-03-18
05060548211356Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippe100232026-03-18
05060548210731Versius Endoscope 0° (vLimeLite)909102026-03-11
05060548211226Versius Surgeon ConsoleV-SS-10202026-03-09
05060548211233Versius Instrument Bedside UnitV-SS-20202026-03-09
05060548211240Versius Visualisation Bedside UnitV-SS-30202026-03-09
05060548210229Versius Bedside Unit Cable (Short)90800/52026-03-10
05060548210366Versius Bedside Unit Cable (Long)90800/102026-03-10
05060548210526Versius Monopolar Instrument Cable905002026-03-10
05060548210724Versius Endoscope 30° (compatible with vLimeLite)909092026-03-10
05060548210748Versius Camera Head (compatible with vLimeLite)909112026-03-10
05060548210502Versius Bipolar Instrument Cable903002026-03-09
05060548210519Versius Bipolar Bedside Unit Cable904002026-03-09
05060548210533Versius Monopolar Bedside Unit Cable906002026-03-09
05060548211257Versius Needle Holder101202026-03-09
05060548211271Versius Fenestrated Grasper103202026-03-09
05060548211295Versius Curved Scissors105202026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060548211349Versius Insulating Sleeve Accessory – Carton Pack (Qty 12 x 10021), 10022CMR SURGICAL LIMITEDSCV2026-03-18
05060548211356Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippeCMR SURGICAL LIMITEDSCV2026-03-18
05060548210731Versius Endoscope 0° (vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-11
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
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