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Vycor Viewsite Brain Access System with Alignment Clip

FDA UDI

Class II (US FDA UDI)

by Vycor Medical, Inc.

Identity

Trade Name
Vycor Viewsite Brain Access System with Alignment Clip FDA UDI
Generic Name
Neurosurgical retraction cannula FDA UDI
Device Name
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
TC211505AC FDA 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
00859261006180 FDA UDI
510(k) Number
K202694 FDA UDI
FDA Product Code
GZT FDA UDI
GMDN Term
Neurosurgical retraction cannula FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA 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
Sterilization Method
Radiation Sterilization FDA UDI

Category: Neurosurgical retraction cannula

Vycor Viewsite Brain Access System with Alignment Clip by Vycor Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical retraction cannula.

Cleared under the same submission

K202694 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vycor Medical, Inc.

Sources (1)

  • FDA UDI 812bea2f-db4f-4006-a5ad-606f9c593ee2 34 fields · synced May 30, 2026