# K162802: Barrx Anorectal RFA Wand

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jan 24, 2017 after 111 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: 19 generations back to K943450 (1995). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150251: Barrx Anorectal RFA Wand, Covidien, LLC (2015) Summary page 4.
- K112454: HALO60 Ablation Catheter, Barrx Medical, Inc. (2012) Summary page 4.

## Indications for use
The Barrx™ Anorectal RFA Wand is indicated for use in the coagulation of bleeding and non-bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiomata, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN).

Source page: https://510kreport.com/device/K162802
Methodology: https://510kreport.com/methodology