# K202623: Novapak Nasal Sinus Packing and Stent

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed
- Decided: Dec 8, 2020 after 89 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.
No later device cites it as a predicate yet.
0 of 7 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 4.

## Indications for use
The Novapak Nasal Sinus Packing and Stent is intended for use in patients undergoing nasal/sinus surgery as a space occupying packing to: • Separate tissue or structures compromised by surgical trauma. • Separate and prevent adhesions between mucosal surfaces in the nasal cavity. • Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption, and platelet aggregation. • Act as an adjunct to aid in the natural healing process. Novapak is indicated for use as a nasal packing to treat epistaxis.

Source page: https://510kreport.com/device/K202623
Methodology: https://510kreport.com/methodology