510(k) · Cleared
ClearedMerogel Injectable Bioresorbable Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Cleared on Apr 26, 2007 as substantially equivalent to K043035 (Genzyme Corporation, 2005) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1982. 1 later device descends from it.
- Decided
- Apr 26, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- NHB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K821150 (1982). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 3 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 2 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 1 generation backK043035 Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005
- This deviceK070886 Merogel Injectable Bioresorbable StentMedtronic, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK122434 Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and…Medtronic Xomed · 2012
Most influential descendants
Showing 1 of 1 · See all- K122434Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic GelMedtronic Xomed · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −3 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −2 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −1 | K043035 | Sepragel Ent Bioresorbable Packing/Stent | Genzyme Corporation | 2005 | — |
| 0 (this device) | K070886 | Merogel Injectable Bioresorbable Stent | Medtronic, Inc. | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K043035 | Sepragel Ent Bioresorbable Packing/StentSummary page 1…vice claiming equivalence to MeroGel Injectable Bioresorbable Stent is equivalent to Genzyme Corporation's Sepragel TM ENT Nasal/Sinus and Otologic Dressing, K043035 and Medtronic Xomed's MeroGelTM Otologic Pack, KOO1 148. Device Description MeroGel Injectable Bioresorbable Stent i… | 2005 |
| * | K001148 | Merogel Otologic Pack | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122434 | Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel | 2012 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K122434 (Medtronic Xomed, 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K043035.
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. 2007, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070886: Merogel Injectable Bioresorbable Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070886
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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