# K973273: Xomed T-Stent, Frontal Sinus Stent

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Sep 29, 1997 after 27 days
- Product code: KAM (Cannula, Sinus)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 its predicate without a number.
- (no number) Rains stent: named in the summary without a submission number

## Indications for use
This device is intended for use as a postoperative stent to maintain an opening to the frontal sinus during the first 7 to 14 days following sinus surgical procedures. The self-retaining stent provides for the ventilation and drainage of fluids from the frontal sinus and helps prevent obstruction by adhesions when used alone or with other nasal stents or packs Indications: Any sinus surgery requiring the placement of a drainage stent for the frontal sinus.

Source page: https://510kreport.com/device/K973273
Methodology: https://510kreport.com/methodology