# K150029: Habib EUS RFA

- Pathway: 510(k) (Traditional)
- Applicant: Emcision, Ltd.
- Decided: Jun 24, 2015 after 167 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: 3 generations back to K945531 (1995). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123061: Ace Monopolar Attachment, Bioeconeer, Inc. (2013) Summary page 4.
- K140495: Leveen Standard Needle Electrode, Leveen Coaccess Needle Electrode, Boston Scientific Corp (2014) Summary page 4.

## Most influential descendants
- K181249: EUSRA RF Electrode (2018), 2 descendants of its own
- K240932: HybridTherm System (2024), 1 descendant of its own
- K161305: Habib EUS RFA (2016), 1 descendant of its own
- K251108: Erbe ESU Model VIO® 3n with Accessories (2025), 0 descendants of its own
- K170990: Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator (2017), 0 descendants of its own

## 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/K150029
Methodology: https://510kreport.com/methodology