# K141704: Novashield Injectable Nasal Packing and Stent

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Oct 6, 2014 after 104 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: 7 generations back to K896068 (1990). 41 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120958: Posisep and Posisep X Hemostat Dressings, Hemostasis, LLC (2012) Summary page 4.
- K113585: Nasal/Epistaxis Pack, Cogent Therapeutics, LLC (2012) Summary page 4.

## Most influential descendants
- K172179: Chitogel Endoscopic Sinus Surgery Kit (2017), 1 descendant of its own
- K230142: Epi-Stop Nasal Gel/epistaxis pack (2023), 0 descendants of its own

## Indications for use
NovaShieldTM is indicated 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 NovaShieldTM is indicated for use as a nasal packing to treat epistaxis.

Source page: https://510kreport.com/device/K141704
Methodology: https://510kreport.com/methodology