Who else makes this device?

Name: Venom Multigen 2
Brand: Venom Multigen 2

Venom Multigen 2 · Generator, Lesion, Radiofrequency → Neurology

2manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

2recalls on this code

Who Else Makes It

Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GXD
Manufacturer	City	Province	Registered as	Device types
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
Cathay Manufacturing Corp.	Shanghai	Shanghai	Contract manufacturer	5

Record

Regulatory record for Venom Multigen 2
Listed by	Stryker GmbH, Switzerland
FDA product code	GXD
Device type	Generator, Lesion, Radiofrequency
Device class	Class 2
Regulation	21 CFR 882.4400
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Record published	2017-06-15
Record revised	2024-05-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment temperature -34 to 65 °C
Sizes	Length 100 to 150 mm

Catalogue Numbers

Catalogue numbers for Venom Multigen 2
Catalogue number	Size	Status
8400-825-015	Length 150.0 mm	In distribution
8400-825-010	Length 100.0 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Generator, Lesion, Radiofrequency	Boston Scientific Neuromodulation Corporation	68
Generator, Lesion, Radiofrequency	Stryker Leibinger Gmbh & Co. KG	58
OneRF Ablation System	Neuroone Medical Technologies Corp.	7
GX1™	Boston Scientific Neuromodulation Corporation	7
Accurian	Medtronic Sofamor Danek, Inc.	7
Multigen 2	Stryker GmbH	6
Avanos*	Avanos Medical, Inc.	4
OWL	Diros Technology, Inc.	4
NeuroTherm™	Neurotherm, Inc.	3
Halyard	Avanos Medical, Inc.	3
Relievant	Relievant Medsystems	2
IonicRF™	St. Jude Medical	2

Showing 12 of 26. All products under Generator, Lesion, Radiofrequency

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K170242	2017-05-25

Recalls

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-10-11	Class III	Labeling Change Control	Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use incorrectly contained instructions supporting the sterilizati	2,675	2017-07-25
2010-04-13	Not classified	Component design/selection	This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside o	3364 all products	2011-05-16

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.

Venom Multigen 2