# K191732: Sutter RaVoR Bipolar Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Sutter Medizintechnik GmbH
- Decided: Aug 30, 2019 after 63 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 4.

## Indications for use
Sutter RaVoR™ Bipolar Electrodes are to be connected to the bipolar output of the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar Electrodes are indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery. The RaVoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring. The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.

Source page: https://510kreport.com/device/K191732
Methodology: https://510kreport.com/methodology