ViewSite Brain Access System

EUDAMEDFDA UDI

Class III (EU MDR)

Ref TC120805AC

by Vycor Medical Inc.

Identity

Trade Name: ViewSite Brain Access System EUDAMED
Vycor Viewsite Brain Access System with Alignment Clip FDA UDI
Generic Name: Neurosurgical retraction cannula FDA UDI
Device Name: 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
Model / Reference: TC120805AC 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

Identifiers

Primary DI / UDI-DI: 00859261006241 EUDAMEDFDA UDI
Basic UDI-DI: B-00859261006241 EUDAMED
510(k) Number: K202694 FDA UDI
FDA Product Code: GZT 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 UDI
Regulation Number: 882.4800 FDA UDI
Market of Registration: Sweden EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

ViewSite Brain Access System by Vycor Medical, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-00859261006241	Class III	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Vycor Medical Inc.
EUDAMED SRN: US-MF-000007171
Authorised Representative: MediMark Europe Sarl. FR-AR-000000182

Sources (2)

EUDAMED fd5360a1-2b82-442f-bbf2-00bd54c490a1 61 fields · synced Jul 13, 2026
FDA UDI ad5f83b7-1b4a-4a44-99eb-92d62511b63a 34 fields · synced May 30, 2026