# K962761: Reigel Tunneling Device

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Oct 11, 1996 after 87 days
- Product code: GYK (Instrument, Shunt System Implantation)
- Device class: 1
- Regulation: 21 CFR 882.4545
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen.

Source page: https://510kreport.com/device/K962761
Methodology: https://510kreport.com/methodology