# K070886: Merogel Injectable Bioresorbable Stent

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Apr 26, 2007 after 27 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: 4 generations back to K821150 (1982). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043035: Sepragel Ent Bioresorbable Packing/Stent, Genzyme Corporation (2005) Summary page 1.
- K001148: Merogel Otologic Pack, Xomed, Inc. (2000)

## Most influential descendants
- K122434: Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel (2012), 0 descendants of its own

## Indications for use
MeroGel Injectable Bioresorbable Stent 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 Stent 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/K070886
Methodology: https://510kreport.com/methodology