# K982731: Merogel Nasal Dressing and Sinus Stent

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Feb 2, 1999 after 181 days
- Product code: EMX (Balloon, Epistaxis)
- Device class: 1
- Regulation: 21 CFR 874.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
49 later devices descend from it; 7 cite it directly.
0 of 50 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) Merocel® Sinus-Pak™: named in the summary without a submission number
- (no number) Merocel® Standard Nasal Dressing: named in the summary without a submission number

## Most influential descendants
- K012532: Sepragel Sinus (2001), 47 descendants of its own
- K993362: Hylasine (2000), 35 descendants of its own
- K033666: Hemaderm (2003), 29 descendants of its own
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), 28 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own

## Indications for use
Xomed MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space occupying dressing and/or stent, to separate mucosal surfaces and help control minimal bleeding following surgery.

Source page: https://510kreport.com/device/K982731
Methodology: https://510kreport.com/methodology