# K050340: Micromedics Sphenoid Sinus Stent

- Pathway: 510(k) (Traditional)
- Applicant: Micromedics, Inc.
- Decided: Apr 27, 2005 after 75 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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.

## Most influential descendants
- K072891: Sinus Spacer (2008), 3 descendants of its own
- K083574: Relieva Stratus Microflow Spacer (2009), 2 descendants of its own
- K093594: Modification to Relieva Stratus Microflow Spacer (2010), 1 descendant of its own
- K110687: Relieva Stratus Pro Microflow Spacer (Frontal) (2011), 0 descendants of its own

## Indications for use
Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus during the first 14 days following sinus surgery. 'Provides for ventilation and drainage of fluids from the sphenoid sinus and helps prevent obstruction by adhesions.

Source page: https://510kreport.com/device/K050340
Methodology: https://510kreport.com/methodology