# K202694: Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)

- Pathway: 510(k) (Traditional)
- Applicant: Vycor Medical, Inc.
- Decided: Jan 14, 2021 after 120 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002931 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060973: Vycor Surgical Access Systems, Vycor Medical, LLC (2006) Summary page 4.

## Indications for use
The Vycor Viewsite Brain Access System (VBAS) is intended to provide for access and allow for visualization of the surgical field during brain and spine surgery.

Source page: https://510kreport.com/device/K202694
Methodology: https://510kreport.com/methodology