# K082276: Synthemed Device

- Pathway: 510(k) (Traditional)
- Applicant: Synthemed, Inc.
- Decided: Nov 18, 2008 after 99 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972082 (1997). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ, Polyganics B.V., (2005) Summary page 1.
- K012532: Sepragel Sinus, Genzyme Corp. (2001) Summary page 1.
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent, Medtronic Xomed, Inc. (2004) Summary page 1.

## Most influential descendants
- K092401: Sinexus Sinus Stent Gen 2, Model 1999-25 (2009), 1 descendant of its own
- K170913: Composite Removable Sinus Stent System (2017), 0 descendants of its own
- K160101: SinuBand (2016), 0 descendants of its own

## Indications for use
The SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces.

Source page: https://510kreport.com/device/K082276
Methodology: https://510kreport.com/methodology