# K983624: Giltech Plus Connecting Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Giltech Plus, Inc.
- Decided: Mar 18, 1999 after 154 days
- Product code: KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration)
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 Giltech Plus Connecting Tube Sets will consist of: (a) Insufflation Tubing Sets (b) Suction / Irrigation Sets (c) Urinary Extension Tubing (d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.

Source page: https://510kreport.com/device/K983624
Methodology: https://510kreport.com/methodology