# K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint

- Pathway: 510(k) (Traditional)
- Applicant: Hemostasis, LLC
- Decided: Mar 27, 2013 after 223 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; 2 cite 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 2.
- K113585: Nasal/Epistaxis Pack, Cogent Therapeutics, LLC (2012)
- K982731: Merogel Nasal Dressing and Sinus Stent, Xomed, Inc. (1999) Summary page 2.
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent, Medtronic Xomed, Inc. (2004) Summary page 2.

## Most influential descendants
- K181696: ChitoZolve (2018), 0 descendants of its own
- K141816: Hemopore (2014), 0 descendants of its own

## Indications for use
PosiSep and PosiSep M X Hemostat Dressing/Intranasal Splint are indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: * Separate tissue or stmuctures 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; and * Act as an adjunct to aid in the natural healing process PosiSep and PosiSep M X are intended for use under the direction of a licensed healthcare provider.

Source page: https://510kreport.com/device/K122494
Methodology: https://510kreport.com/methodology