# K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Sep 10, 2004 after 108 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
No predicates in its family tree.
25 later devices descend from it; 8 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MeroGel™ Nasal Dressing and Sinus Stent: named in the summary without a submission number
- (no number) Seprapack/Sepragel (Genzyme): named in the summary without a submission number

## Most influential descendants
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ (2005), 17 descendants of its own
- K113585: Nasal/Epistaxis Pack (2012), 7 descendants of its own
- K063308: Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200 (2006), 4 descendants of its own
- K082276: Synthemed Device (2008), 3 descendants of its own
- K070496: Advacoat Sinus Gel and Stent (2007), 3 descendants of its own

## Indications for use
MeroPackTM Bioresorbable Nasal Dressing and Sinus Stent is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; to help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and to prevent lateralization of the middle turbinate during the postoperative period.

Source page: https://510kreport.com/device/K041381
Methodology: https://510kreport.com/methodology