# K233591: Stylus

- Pathway: 510(k) (Traditional)
- Applicant: Degania Silicone, Ltd.
- Decided: May 31, 2024 after 205 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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
Longest line of descent: 1 generation back to K042300 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042300: Amt Introducer: Mini Button Delivery System, Applied Medical Technology, Inc. (2004) Summary page 4.

## Indications for use
The Stylus is intended to assist in the placement of Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button by providing temporary feeding tube stability during insertion through patient stoma tract.

Source page: https://510kreport.com/device/K233591
Methodology: https://510kreport.com/methodology