# K161661: Thermi RF Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Thermi
- Decided: Aug 12, 2016 after 57 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: 18 generations back to K943450 (1995). 104 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130689: Symphony RF Generator, Thermigen, Inc. (2013) Summary page 4.
- K033981: Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975, Smith & Nephew, Inc. (2004) Summary page 4.

## Most influential descendants
- K170116: Thermi Injectable RF Electrodes (2017), 2 descendants of its own
- K173582: ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes (2018), 1 descendant of its own
- K222709: Retraction, CWM-910T, APOLEX Tite (2023), 0 descendants of its own

## Indications for use
The Thermi RF accessories used with the Thermi RF Generator System are indicated: * for use in dermatological and general surgical procedures for electrocoagulation and hemostasis * to create lesions in nervous tissue when used in combination with Thermi RF Generator.

Source page: https://510kreport.com/device/K161661
Methodology: https://510kreport.com/methodology