# K984583: The Bioplate Shunt Connector

- Pathway: 510(k) (Traditional)
- Applicant: Biomedics
- Decided: Mar 15, 1999 after 81 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Bioplate Shunt Connector is indicated for use in the joining and fixation of silicone rubber catheters with a nominal 1.D. of 1.25 mm (.050") when combined with nonabsorbable sutures in a surgical application. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Source page: https://510kreport.com/device/K984583
Methodology: https://510kreport.com/methodology