# K001153: Modification to Steathstation Treatment Guidance Platform

- Pathway: 510(k) (Special)
- Applicant: Medtronic Surgical Navigation
- Decided: May 3, 2000 after 23 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013428: Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System (2002), 1 descendant of its own
- K041897: Mayfield Acciss II Image Guided Surgery System, Model 2002-01 (2005), 0 descendants of its own

## Recalls of this device
- Oct 31, 2003 · Not classified · Z-0231-04: Surgical devices intended for single use were not labeled for single use.

Source page: https://510kreport.com/device/K001153
Methodology: https://510kreport.com/methodology