# K060973: Vycor Surgical Access Systems

- Pathway: 510(k) (Traditional)
- Applicant: Vycor Medical, LLC
- Decided: Jul 26, 2006 after 107 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002931 (2000). 6 ancestors in all.
10 later devices descend from it; 2 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043602: Quadrant Retractor System, Medtronic Sofamor Danek (2005) Summary page 2.
- K895395: V. Mueller Rhoton Self-Retaining Brain Retractor, Baxter Healthcare Corp (1989) Summary page 2.
- K830332: Budde-Halo Retractor, Ohio Medical Instrument Co., Inc. (1983) Summary page 2.
- K896156: Compass (TM) Stereotactic Retractor System, Stereotactic Medical Systems, Inc. (1989) Summary page 2.

## Most influential descendants
- K120691: Brain Port (2012), 8 descendants of its own
- K182211: Aurora Surgiscope System (2019), 4 descendants of its own
- K191861: Aurora Surgiscope System (2019), 3 descendants of its own
- K201840: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) (2020), 2 descendants of its own
- K150378: NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (2015), 2 descendants of its own

## Recalls of this device
- Aug 21, 2012 · Class I · Z-0673-2013: Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.

## Indications for use
To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

Source page: https://510kreport.com/device/K060973
Methodology: https://510kreport.com/methodology