FDA.reportPublic FDA data

Versius Endoscope 30° (compatible with vLimeLite)

Primary DI
05060548210724
Brand
Versius Endoscope 30° (compatible with vLimeLite)
Company
CMR SURGICAL LIMITED
Model
90909
Published
2026-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05060548210724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060548210724050605482107245060548210724

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope telescopeAn optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
219860797
Device count
1
Lot or batch
true
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
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
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
05060548211264Versius Bipolar Maryland Grasper102202026-03-09
05060548211271Versius Fenestrated Grasper103202026-03-09
05060548211288Versius Monopolar Hook104202026-03-09
05060548211295Versius Curved Scissors105202026-03-09
05060548211301Versius Monopolar Curved Scissors106202026-03-09
05060548211318Versius Insulating Sleeve Accessory100212026-03-09

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
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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