# K161305: Habib EUS RFA

- Pathway: 510(k) (Traditional)
- Applicant: Emcision, Ltd.
- Decided: Jul 7, 2016 after 58 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945531 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150029: Habib EUS RFA, Emcision, Ltd. (2015) Summary page 4.

## Most influential descendants
- K170990: Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator (2017), 0 descendants of its own

## Recalls of this device
- Nov 18, 2019 · Class II · Z-0667-2020: During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from t
- Nov 18, 2019 · Class II · Z-0668-2020: During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from t

## Indications for use
The Habib EUS RFA 6700 is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator.

Source page: https://510kreport.com/device/K161305
Methodology: https://510kreport.com/methodology