# K143420: SYMBIS Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Oct 30, 2015 after 336 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002053 (2000). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101791: Rosa Surgical Device, Medtech S.A.S (2010) Summary page 5.

## Indications for use
The SYMBIS Surgical System is a computer-controlled electromechanical arm. The manipulation of the arm is performed by the neurosurgeon. It is intended to be used in the operating room for the spatial positioning and orientation of a biopsy instrument guide. Guidance is based on a pre-operative plan developed using the Medtronic StealthStation® along with fiducial marker or optical registration. The system is intended for use by neurosurgeons to guide a biopsy needle. It is intended for use by trained physicians for needle based biopsy.

Source page: https://510kreport.com/device/K143420
Methodology: https://510kreport.com/methodology