# K944463: CRW-1 System

- Pathway: 510(k) (Traditional)
- Applicant: Radionics Software Applications, Inc.
- Decided: Oct 26, 1995 after 409 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 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
- K961858: Cosgrove Depth Electrode Kit (Cdek) (1996), 18 descendants of its own
- K991522: Microtargeting Electrode (2000), 17 descendants of its own
- K033173: Micro Targeting Electrode (2004), 16 descendants of its own
- K041604: Macro-Micro Depth Electrode (2004), 12 descendants of its own
- K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes (2006), 11 descendants of its own

## Recalls of this device
- Aug 21, 2015 · Class II · Z-0025-2016: Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufact
- Aug 9, 2012 · Class II · Z-2428-2012: T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, 
- Aug 9, 2012 · Class II · Z-2429-2012: T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, 
- Jan 12, 2011 · Not classified · Z-1400-2011: Overall length of the intubation hoop in the HRAIM Intubation Head Ring Assembly is too long and will not allow a device to to attach

Source page: https://510kreport.com/device/K944463
Methodology: https://510kreport.com/methodology