510(k) · Cleared
ClearedMerogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Cleared on Oct 31, 2012 as substantially equivalent to K070886 (Medtronic, Inc., 2007) after an 82-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- Oct 31, 2012
- Review
- 82 days
- Class
- Class II
- Product code
- NHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K821150 (1982). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 4 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 3 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 2 generations backK043035 Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005
- 1 generation backK070886 Merogel Injectable Bioresorbable StentMedtronic, Inc. · 2007
- This deviceK122434 Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and…Medtronic Xomed · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −4 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −3 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −2 | K043035 | Sepragel Ent Bioresorbable Packing/Stent | Genzyme Corporation | 2005 | — |
| −1 | K070886 | Merogel Injectable Bioresorbable Stent | Medtronic, Inc. | 2007 | — |
| 0 (this device) | K122434 | Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel | Medtronic Xomed | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHB device
- #1 K251790 SeptAlignscore 14.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070886 | Merogel Injectable Bioresorbable StentSummary page 1…to MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel (MeroGel) is equivalent to Medtronic Xomed's MeroGel Injectable Bioresorbable Stent, K070886. Device Description Merocel is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyal… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All NHB devicesNHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NHB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NHB
Too few NHB 510(k)s in any year since 2007 to give a median.
Recalls per year · NHB
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHB
22in 2025
MAUDE reports naming product code NHB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 2 | — | 1 | 27 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (105 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122434: Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122434
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026