# K031029: Arthrocare Bipolar Electrosurgery System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jun 19, 2003 after 79 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 K000778 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955531: Arthrocare Bipolar Loop Electrode System, Arthrocare Corp. (1996) Summary page 1.
- K010568: Arthrocare Urology Electrosurgery System, Arthrocare Corp. (2001) Summary page 1.
- K020832: Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands, Arthrocare Corp. (2002)
- K022543: Arthrocare Bipolar Electrosurgery System, Arthrocare Corp. (2002)
- K003569: Plasmakinetic Endourology System, Gyrus Medical, Ltd. (2000)

## Indications for use
The ArthroCare Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUP), as well as tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution, Ringer’s lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.

Source page: https://510kreport.com/device/K031029
Methodology: https://510kreport.com/methodology