510(k) · Cleared
ClearedCelon Ent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celon AG Medical Instruments · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 26, 2003 as substantially equivalent to K973478 (Arthrocare Corp., 1998) and 4 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 26, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K943450 (1995). 19 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 4 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 2 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 1 generation backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- This deviceK032838 Celon Ent SystemCelon AG Medical Instruments · 2003
- Descendant · cites it directly · 0 of its ownK252043 Bipolar applicator CelonProBreath (WB990310); Bipolar applicator…Olympus Winter & Ibe GmbH · 2025
- Descendant · cites it directly · 0 of its ownK191732 Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH · 2019
- Descendant · cites it directly · 0 of its ownK160639 Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH · 2016
Most influential descendants
Showing 3 of 3 · See all- K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH · 2025 · cites it directly0descendants
- K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH · 2019 · cites it directly0descendants
- K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −4 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −2 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −1 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| 0 (this device) | K032838 | Celon Ent System | Celon AG Medical Instruments | 2003 | — |
| +1 | K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep… | Olympus Winter & Ibe GmbH | 2025 | — |
| +1 | K191732 | Sutter RaVoR Bipolar Electrodes | Sutter Medizintechnik GmbH | 2019 | — |
| +1 | K160639 | Electrosurgical Generator ESG-200 | Olympus Winter & Ibe GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K973478 | Arthrocare Sinus Electrosurgery SystemSummary page 2…to the following currently marketed devices: Device 510(k) Number Date Cleared ArthroCare ACCENTElectrosurgery System K973478 January 9Ih, 1998 ArthroCare ENTec Reflex Wand Electrodes KO00036 February 4'h, 2000 ArthroCare EN… | 1998 |
| * | K000036 | Entec Reflex Wand 55, Model E4055-00 | 2000 |
| * | K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01 | 2000 |
| * | K971450 | Somnoplasty SystemSummary page 2…KO00036 February 4'h, 2000 ArthroCare ENTec Reflex Wand Electrodes KO00778 May 3rd, 2000 Somnus Somnoplasty System K97 1450 July 17'h, 1997 Somnus Somnoplasty System K973618 December 1gth, 1997 It complies wi… | 1997 |
| * | K973618 | Somnoplasty SystemSummary page 2…es KO00778 May 3rd, 2000 Somnus Somnoplasty System K97 1450 July 17'h, 1997 Somnus Somnoplasty System K973618 December 1gth, 1997 It complies with the same or equivalent standards and has the same intended use. Device Descr… | 1997 |
What descends from it? (3)
3 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 8 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K252043 (Olympus Winter & Ibe GmbH, 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K973478.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
This application system, comprising the CelonLab ENT power control unit and the CelonProBreafh, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including: CelonProBreath: Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates CelonProSleep: Submucosal tissue shrinkage and tissue coagulation in…
Read the full statement (98 words)
This application system, comprising the CelonLab ENT power control unit and the CelonProBreafh, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including:
CelonProBreath: Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates
CelonProSleep: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring
CelonProSleep PLUS: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring
The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032838 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032838: Celon Ent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032838
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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