What is FDA product code SCV?

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.

General & Plastic Surgery › SurgicalModular Electromechanical Surgical System

Versius Bipolar Fenestrated Grasper

Name: Versius Bipolar Fenestrated Grasper
Brand: Versius Bipolar Fenestrated Grasper

Catalogue number 11220, listed by CMR Surgical Limited, United Kingdom, under Modular Electromechanical Surgical System. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code SCV
Manufacturer	City	Province	Registered as	Device types
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24

Record

Regulatory record for Versius Bipolar Fenestrated Grasper
Listed by	CMR Surgical Limited, United Kingdom
FDA product code	SCV
Device type	Modular Electromechanical Surgical System
Device class	Class 2
Regulation	21 CFR 878.4964
Establishment	Specification developer, Manufacturer
510(k)	K252111
Record published	2026-03-09

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Versius Bipolar Fenestrated Grasper
Catalogue number	Size	Status
11220		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hugo RAS	Covidien LP	29
Versius Monopolar Bedside Unit Cable	CMR Surgical Limited	1
Versius Bedside Unit Cable (Short)	CMR Surgical Limited	1
Versius Instrument Bedside Unit	CMR Surgical Limited	1
Versius Insulating Sleeve Accessory → Carton Pack (Qty 12 x 10021), 10022	CMR Surgical Limited	1
Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippe	CMR Surgical Limited	1
Versius Surgeon Console	CMR Surgical Limited	1
Versius Bipolar Bedside Unit Cable	CMR Surgical Limited	1
Versius Endoscope 0° (vLimeLite)	CMR Surgical Limited	1
Versius Camera Head (compatible with vLimeLite)	CMR Surgical Limited	1
Versius Fenestrated Grasper	CMR Surgical Limited	1
Versius Visualisation Bedside Unit	CMR Surgical Limited	1

Showing 12 of 24. All products under Modular Electromechanical Surgical System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252111	2025-12-16
DEN230078	2024-10-11

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Versius Bipolar Fenestrated Grasper
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
CMR Surgical Limited	510(k) number	2026-06-09	Class II	Software design (manufacturing process)	Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.	2

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.