# K160811: CRW Stereotactic System

- Pathway: 510(k) (Abbreviated)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 6, 2016 after 257 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: 1 generation back to K944463 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944463: CRW-1 System, Radionics Software Applications, Inc. (1995) Summary page 4.

## Indications for use
The CRW Stereotactic System is a stereotactic system to be used for neurosurgical procedures that require precise target localization, such as craniotomies, biopsies, and functional stereotaxy. Localization is performed using CT or MR imaging.

Source page: https://510kreport.com/device/K160811
Methodology: https://510kreport.com/methodology