# K994262: Frontal Sinus Trephination Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Feb 8, 2000 after 53 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
Longest line of descent: 1 generation back to K925176 (1993). 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)
- K925176: Vansonnenberg Chest Drainage Catheter All Purpose, Boston Scientific Corp (1993) Summary page 2.
- (no number) Medtronic Xomed Frontal Sinus Mini-Trephine Set irrigation cannula: named in the summary without a submission number
- (no number) Common peritoneal catheters: named in the summary without a submission number
- (no number) Catheter Plug marketed by Bard Medical: named in the summary without a submission number

## Indications for use
The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.

Source page: https://510kreport.com/device/K994262
Methodology: https://510kreport.com/methodology