# K113585: Nasal/Epistaxis Pack

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Therapeutics, LLC
- Decided: Apr 25, 2012 after 142 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: 4 generations back to K821150 (1982). 17 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 25 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.
- K043035: Sepragel Ent Bioresorbable Packing/Stent, Genzyme Corporation (2005) Summary page 1.
- K972459: Rhinocell Nasal Packings, Boston Medical Products, Inc. (1997) Summary page 1.
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent, Medtronic Xomed, Inc. (2004) Summary page 1.
- K002972: Merogel Control Gel Ent Surgical Dressing, Medtronic Xomed (2000) Summary page 1.

## Most influential descendants
- 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
- K230142: Epi-Stop Nasal Gel/epistaxis pack (2023), 0 descendants of its own
- K181696: ChitoZolve (2018), 0 descendants of its own

## Indications for use
The Nasal/Epistaxis Pack is a sterile, singe use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing. The Nasat/Epistaxis Pack 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 during mesothelial cell regeneration in the nasal cavity; * Help control minimal bleeding following surgery or trauma; * Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; * Act as an adjunct to aid in the natural healing process. The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.

Source page: https://510kreport.com/device/K113585
Methodology: https://510kreport.com/methodology