# K252043: Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Sep 23, 2025 after 85 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: 6 generations back to K943450 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032838: Celon Ent System, Celon AG Medical Instruments (2003) Summary page 6.

## Indications for use
Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT). Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically: - Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates. The product is intended to be used for patients from 2 years and up. Bipolar applicator CelonProSleep plus is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT). Bipolar applicator CelonProSleep plus is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically: - Shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring. The product is intended to be used for patients from 18 years up.

Source page: https://510kreport.com/device/K252043
Methodology: https://510kreport.com/methodology