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Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Cli…

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K202694Ref TC171107AC Ref TC211505 Ref TC211503AC Ref TC120805

by Vycor Medical, Inc.

Identity

Trade Name
ViewSite Brain Access System EUDAMED
Vycor Viewsite Brain Access System with Alignment Clip FDA UDI
Vycor Viewsite Brain Access System FDA UDI
Generic Name
Neurosurgical retraction cannula FDA UDI
Device Name
ViewSite Brain Access System (VBAS) TC171107AC EUDAMED
Viewsite Brain Access System TC211505 EUDAMED
ViewSite Brain Access System (VBAS) TC211503AC EUDAMED
ViewSite Brain Access System EUDAMED
THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor and brain access devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spine. It has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel or port that are secured by a spring-loaded latch. There is also an Alignment Clip (AC) included separately in the packaging that may be optionally attached to aid in the centering of third-party instrumentation, specifically navigational and image guided system (“IGS”) pointers or probes (“pointer”). Each VBAS device allows for the gentle retraction of tissue, visualization of the surgical site and for the manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes. FDA UDI
THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spine. It has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel or port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes. FDA UDI
Model / Reference
TC171107AC EUDAMEDFDA UDI
TC211505 EUDAMEDFDA UDI
TC120805 EUDAMEDFDA UDI
TC211503AC EUDAMEDFDA UDI
Description
THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) WITH ALIGNMENT CLIP (AC) is a family of retractor and brain access devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spine. It has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel or port that are secured by a spring-loaded latch. There is also an Alignment Clip (AC) included separately in the packaging that may be optionally attached to aid in the centering of third-party instrumentation, specifically navigational and image guided system (“IGS”) pointers or probes (“pointer”). Each VBAS device allows for the gentle retraction of tissue, visualization of the surgical site and for the manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes. FDA UDI
THE VYCOR VIEWSITE BRAIN ACCESS SYSTEM (VBAS) is a family of retractor and brain access devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spine. It has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel or port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes. FDA UDI

Identifiers

Primary DI / UDI-DI
00859261006203 EUDAMEDFDA UDI
00859261006098 EUDAMEDFDA UDI
00859261006036 EUDAMEDFDA UDI
00859261006197 EUDAMEDFDA UDI
Basic UDI-DI
B-00859261006203 EUDAMED
B-00859261006098 EUDAMED
B-00859261006197 EUDAMED
B-00859261006036 EUDAMED
510(k) Number
K202694 FDA 510(k)FDA UDI
K060973 FDA UDI
FDA Product Code
GZT FDA 510(k)FDA UDI
EMDN Code
K01020106 MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE EUDAMED
GMDN Term
Neurosurgical retraction cannula FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 882.4800 FDA 510(k)
Regulation Number
882.4800 FDA 510(k)FDA UDI
Market of Registration
Sweden EUDAMED
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

The Viewsite Brain Access System (VBAS) is a self-retaining retractor designed for neurosurgical procedures. It provides clear, unobstructed access to the brain by retracting soft tissue and dura, facilitating precise surgical intervention while minimizing trauma to surrounding structures.

The VBAS is supplied as a reusable device, intended for use in sterile operating room environments. It is classified as MRI-safe and comes in various sizes to accommodate different anatomical requirements. Authorized under FDA 510(k) and MDD regulations, the system includes both the standard VBAS and the VBAS with Alignment Clip (VBAS AC) for enhanced stability during procedures.

Frequently asked questions

What types of neurosurgical procedures is the VBAS Family designed to assist with, and how does it improve access to the brain?

The VBAS Family is designed to assist in neurosurgical procedures by providing clear, unobstructed access to the brain. It achieves this through its self-retaining retractor function, which gently retracts soft tissue and dura, minimizing trauma to surrounding structures. This design allows surgeons to perform precise interventions with reduced risk of complications from tissue displacement or damage.

Is the VBAS Family reusable, and if so, what considerations should be taken for its use in sterile operating room environments?

Yes, the VBAS Family is supplied as a reusable device, intended specifically for sterile operating room environments. Since it is reusable, proper sterilization protocols must be followed between uses to ensure patient safety and device efficacy. The system’s design supports repeated use while maintaining its MRI-safe classification, which is critical for intraoperative imaging.

What are the key differences between the standard VBAS and the VBAS with Alignment Clip (VBAS AC), and how might they benefit a surgeon?

The standard VBAS provides clear access to the brain through retraction of soft tissue and dura, while the VBAS with Alignment Clip (VBAS AC) includes an additional feature for enhanced stability during procedures. The alignment clip helps secure the retractor in place, reducing the risk of unintended movement and improving precision during delicate neurosurgical interventions.

Are there multiple sizes available for the VBAS Family, and how do they accommodate different anatomical requirements?

Yes, the VBAS Family comes in various sizes to accommodate different anatomical requirements. This modularity ensures that surgeons can select the appropriate retractor size for the patient’s specific anatomy, optimizing access and minimizing trauma during neurosurgical procedures.

What regulatory pathways has the VBAS Family followed, and what does this mean for its use in clinical settings?

The VBAS Family has been authorized under both FDA 510(k) and MDD (Medical Device Directive) regulations. This means the device has undergone evaluation to demonstrate substantial equivalence to legally marketed predicates in the U.S. and compliance with European safety and performance standards. Clinicians can rely on its regulatory clearance as part of their decision-making process for selecting neurosurgical tools.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vycor Medical, Inc.

Sources (9)

  • FDA 510(k) K202694 24 fields · synced Sep 18, 2026
  • FDA UDI f416e08f-8cf4-4646-b48e-c6cf172c3ffd 34 fields · synced May 30, 2026
  • FDA UDI e90b4af1-42c5-4daa-bed6-c995380d3701 34 fields · synced May 30, 2026
  • FDA UDI a67e7710-4d90-4298-ba0b-24ead6edf58a 34 fields · synced May 30, 2026
  • FDA UDI 68682043-fd1d-403c-9883-63b833ed5d65 34 fields · synced May 30, 2026
  • EUDAMED d00ec3b4-4cab-44e9-9055-2492d3b7f0f8 61 fields · synced Jul 9, 2026
  • EUDAMED 408547f6-52c8-4a12-bbcc-57f9f924813e 61 fields · synced Jul 9, 2026
  • EUDAMED b6416c6f-28e7-48fb-80dc-6e8deb59a0e0 61 fields · synced Jul 13, 2026
  • EUDAMED b345d9f6-06cf-42e7-844b-fe673d6be650 61 fields · synced Aug 4, 2026