# K120116: Serf Ablation System Serf Ablation Needle

- Pathway: 510(k) (Traditional)
- Applicant: Thermedical
- Decided: Oct 1, 2012 after 262 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993944: Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive Electrode, Rita Medical Systems (1999) Summary page 1.
- K021329: Rita System, Rita Medical Systems (2002) Summary page 1.
- K984552: Cool-Tip RF System, Radionics, Inc. (1999) Summary page 1.
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 1.
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 1.

## Indications for use
The SERF Ablation System is intended for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Source page: https://510kreport.com/device/K120116
Methodology: https://510kreport.com/methodology