# K120691: Brain Port

- Pathway: 510(k) (Traditional)
- Applicant: Nico Corporation
- Decided: Jun 5, 2012 after 90 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- Recalls of this device: 2 (0 Class I)
- 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.
8 later devices descend from it; 2 cite it directly.
1 of 16 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 2.

## Most influential descendants
- 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
- K172433: NICO BrainPath (2017), 1 descendant of its own

## Recalls of this device
- Jul 17, 2012 · Class II · Z-2200-2012: BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an 
- Jul 17, 2012 · Class II · Z-2201-2012: BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an 

## 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/K120691
Methodology: https://510kreport.com/methodology