# K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ

- Pathway: 510(k) (Traditional)
- Applicant: Polyganics B.V.,
- Decided: Nov 21, 2005 after 110 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: 2 generations back to K972082 (1997). 5 ancestors in all.
17 later devices descend from it; 10 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012532: Sepragel Sinus, Genzyme Corp. (2001) Summary page 1.
- K982731: Merogel Nasal Dressing and Sinus Stent, Xomed, Inc. (1999) Summary page 1.
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent, Medtronic Xomed, Inc. (2004) Summary page 1.

## Most influential descendants
- K113585: Nasal/Epistaxis Pack (2012), 7 descendants of its own
- K082276: Synthemed Device (2008), 3 descendants of its own
- K141704: Novashield Injectable Nasal Packing and Stent (2014), 2 descendants of its own
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint (2013), 2 descendants of its own
- K172179: Chitogel Endoscopic Sinus Surgery Kit (2017), 1 descendant of its own

## Indications for use
Nasopore® nasal dressing 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; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.

Source page: https://510kreport.com/device/K052099
Methodology: https://510kreport.com/methodology