510(k) · Cleared
ClearedSepragel Ent Bioresorbable Packing/Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Corporation · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Jul 11, 2005 as substantially equivalent to K012532 (Genzyme Corp., 2001) and 3 other predicates after a 250-day review. Its family tree reaches back 3 generations to 1982. 10 later devices descend from it.
- Decided
- Jul 11, 2005
- Review
- 250 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K821150 (1982). 13 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 2 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 1 generation backK993362 HylasineBiomatrix, Inc. · 2000
- This deviceK043035 Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005
- Descendant · cites it directly · 7 of its ownK113585 Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK141704 Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK122494 Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013
- Descendant · 3 generations on · 1 of its ownK172179 Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK070886 Merogel Injectable Bioresorbable StentMedtronic, Inc. · 2007
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K113585Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012 · cites it directly7descendants
- K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014 · 2 generations on2descendants
- K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013 · 2 generations on2descendants
- K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017 · 3 generations on1descendant
- K070886Merogel Injectable Bioresorbable StentMedtronic, Inc. · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −2 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −1 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| 0 (this device) | K043035 | Sepragel Ent Bioresorbable Packing/Stent | Genzyme Corporation | 2005 | — |
| +1 | K113585 | Nasal/Epistaxis Pack | Cogent Therapeutics, LLC | 2012 | — |
| +2 | K141704 | Novashield Injectable Nasal Packing and Stent | Medtronic, Inc. | 2014 | — |
| +2 | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2013 | — |
| +3 | K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | 2017 | — |
| +1 | K070886 | Merogel Injectable Bioresorbable Stent | Medtronic, Inc. | 2007 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K012532 | Sepragel SinusSummary page 1…510(k) Number Name of Predicate Device Name of Manufacturer (Town, State) K012532 SepragelTM Sinus Genzyme Corporation (K993362)… | 2001 |
| * | K993362 | HylasineSummary page 1…(Town, State) K012532 SepragelTM Sinus Genzyme Corporation (K993362) Cambridge, MA K001148 MeroGelTM Nasal Otologic Pack… | 2000 |
| * | K001148 | Merogel Otologic PackSummary page 1…K012532 SepragelTM Sinus Genzyme Corporation (K993362) Cambridge, MA K001148 MeroGelTM Nasal Otologic Pack Medtronic Xomed (K002972) (MeroGelTM Control Gel ENT… | 2000 |
| * | K002972 | Merogel Control Gel Ent Surgical DressingSummary page 1…(K993362) Cambridge, MA K001148 MeroGelTM Nasal Otologic Pack Medtronic Xomed (K002972) (MeroGelTM Control Gel ENT Jacksonville, FL Surgical Dressing) 7.7… | 2000 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K113585 (Cogent Therapeutics, LLC, 2012) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K012532.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus,
middle ear and external ear canal surgery as a space-occupying dressing and/or stent
intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control
minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural
healing process. The device is indicated for use in the middle ear following canalplasty,
myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated
following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate
during the post operative period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043035: Sepragel Ent Bioresorbable Packing/Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043035
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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