# K961858: Cosgrove Depth Electrode Kit (Cdek)

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Aug 7, 1996 after 85 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 K811452 (1981). 2 ancestors in all.
18 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)
- K944463: CRW-1 System, Radionics Software Applications, Inc. (1995) Summary page 1.
- K811452: Brown-Roberts-Wells Stereotaxic Sytem, Trent Wells, Inc. (1981) Summary page 1.
- (no number) Todd-Wells Stereotaxic Guide and Accessories: named in the summary without a submission number
- (no number) Radionics Bipolar Forceps: named in the summary without a submission number

## Most influential descendants
- 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
- K170959: DIXI Medical Microdeep Depth Electrode (2017), 5 descendants of its own

## Indications for use
The Cosgrove Depth Electrode Kit (CDEK) allows the user to place and secure epilepsy electrodes via a lateral orthogonal surgical approach or stereotactically using Radionics CRW and BRW Stereotactic Arc Systems which have been cleared through the FDA.

Source page: https://510kreport.com/device/K961858
Methodology: https://510kreport.com/methodology