# K122434: Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel

- Pathway: 510(k) (Special)
- Applicant: Medtronic Xomed
- Decided: Oct 31, 2012 after 82 days
- Product code: NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K821150 (1982). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070886: Merogel Injectable Bioresorbable Stent, Medtronic, Inc. (2007) Summary page 1.

## Indications for use
MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.

Source page: https://510kreport.com/device/K122434
Methodology: https://510kreport.com/methodology