# K032838: Celon Ent System

- Pathway: 510(k) (Traditional)
- Applicant: Celon AG Medical Instruments
- Decided: Sep 26, 2003 after 15 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943450 (1995). 19 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973478: Arthrocare Sinus Electrosurgery System, Arthrocare Corp. (1998) Summary page 2.
- K000036: Entec Reflex Wand 55, Model E4055-00, Arthrocare Corp. (2000)
- K000778: Entec Reflex Wand 55, Model E4055-01, E4045-01, Arthrocare Corp. (2000)
- K971450: Somnoplasty System, Somnus Medical Technologies, Inc. (1997) Summary page 2.
- K973618: Somnoplasty System, Somnus Medical Technologies, Inc. (1997) Summary page 2.

## Most influential descendants
- K252043: Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (2025), 0 descendants of its own
- K191732: Sutter RaVoR Bipolar Electrodes (2019), 0 descendants of its own
- K160639: Electrosurgical Generator ESG-200 (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K032838
Methodology: https://510kreport.com/methodology