Endo Vantage, LLC
US Last updated 23 May 2026
Is this your brand? Sign in to claim this brand
- Devices
- 13
- Registries
- GUDIDFDA 510(k)
- FDA recalls
- 0
Catalogue
SurgicalPreview 2.4.0 Ref 2.4.0
SurgicalPreview 2.2.0 Ref 2.2.0
SurgicalPreview 3.3.0 Ref 3.3.0
SurgicalPreview 3.0.0 Ref 3.0.0
SurgicalPreview 1.2.0 Ref 1.2.0
SurgicalPreview 2.1.0 Ref 2.1.0
SurgicalPreview 1.1.0 Ref 1.1.0
SurgicalPreview 1.0 Ref 1.0
SurgicalPreview 3.2.0 Ref 3.2.0
SurgicalPreview 2.3.0 Ref 2.3.0
SurgicalPreview 3.1.0 Ref 3.1.0
SurgicalPreview 2.6.0 Ref 2.6.0
SurgicalPreview Ref K171534
What Endo Vantage, LLC makes
Endo Vantage, LLC develops vascular modelling software designed for preoperative surgical planning, specifically the SurgicalPreview tool. This software provides 3D visualisation and simulation of vascular structures to assist in surgical interventions, aiding in risk assessment and procedure optimisation.
The company’s products are classified as Class II medical devices and are authorised via FDA 510(k) and UDI registrations. The portfolio is listed under US regulatory frameworks, and the manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Endo Vantage, LLC manufacture?
Endo Vantage, LLC specialises in vascular modelling software, specifically the SurgicalPreview tool. This software is designed for preoperative surgical planning by creating 3D visualisations and simulations of vascular structures. These tools help surgeons assess risks and optimise procedures before surgery, ensuring more informed decision-making.
Where is Endo Vantage, LLC based, and what regulatory frameworks apply to its devices?
Endo Vantage, LLC is based in the United States. Its devices are authorised under US regulatory frameworks, specifically through FDA 510(k) submissions and UDI (Unique Device Identification) registrations. These pathways are used to demonstrate compliance with safety and performance standards for Class II medical devices.
How are Endo Vantage’s devices classified, and why does this matter?
Endo Vantage’s devices are classified as Class II medical devices under FDA regulations. This classification indicates moderate risk, requiring pre-market clearance via the 510(k) pathway to ensure they meet performance and safety requirements. Class II designation also means additional regulatory controls apply, such as post-market surveillance, to monitor device performance after authorisation.
Which regulatory registries or databases list Endo Vantage’s devices?
Endo Vantage’s devices are listed in the FDA’s 510(k) clearance registry and the UDI (Unique Device Identification) database. These registries track authorised devices to ensure transparency in the medical device market and help healthcare providers verify compliance and device details before use.
Information
- Country
- US