# K240932: HybridTherm System

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Aug 5, 2024 after 122 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 K870028 (1987). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181249: EUSRA RF Electrode, Starmed Co., Ltd. (2018) Summary page 5.
- K163450: VIVA combo RF System, Starmed Co., Ltd. (2017) Summary page 5.
- K190823: Erbe ESU Model VIO 3 with Accessories, Erbe Elektromedizin GmbH (2019) Summary page 5.
- K192542: Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde, Modern Medical Equipment Manufacturing, Ltd. (2020) Summary page 5.
- K190651: ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter, Erbe Elektromedizin GmbH (2020) Summary page 5.

## Most influential descendants
- K251108: Erbe ESU Model VIO® 3n with Accessories (2025), 0 descendants of its own

## Indications for use
The Erbe electrosurgical unit (ESU/Generator) model VIO 3 with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation. The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion, devitalization (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation. The HybridTherm probes are intended for ablation and coagulation of soft tissue. The following probes can also be used for cutting tissue: HybridTherm monopolar, eTip and HybridTherm bipolar, eTip.

Source page: https://510kreport.com/device/K240932
Methodology: https://510kreport.com/methodology