# K972398: Stealthstation Passive Instrument Option

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Sep 16, 1997 after 82 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.
283 later devices descend from it; 4 cite it directly.
2 of 284 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) StealthStation® System with active probes: named in the summary without a submission number
- (no number) BrainLAB VectorVision System: named in the summary without a submission number

## Most influential descendants
- K992461: Stealthstation Treatment Guidance Platform (2000), 279 descendants of its own
- K981684: Stealthstation Treatment Guidance Platform (1998), 279 descendants of its own
- K053610: Abaris (2006), 278 descendants of its own
- K121498: Percunav (2012), 222 descendants of its own
- K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own

## Recalls of this device
- May 5, 2015 · Class II · Z-1794-2015: Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.

## Indications for use
The StealthStation® System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.

Source page: https://510kreport.com/device/K972398
Methodology: https://510kreport.com/methodology