# K062458: Ethmoid Sinus Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Sep 15, 2006 after 23 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. The FDA summary names no predicate by number.

## 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
The Ethmoid Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinus within the first 14 days following surgery. The Ethmoid Sinus Spacer also helps to prevent obstruction.

Source page: https://510kreport.com/device/K062458
Methodology: https://510kreport.com/methodology