# K970526: Arthrocare Monopolar Electrosurgery Loop

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: May 28, 1997 after 106 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Circon ACMI predicate electrode products and electrosurgical generators: named in the summary without a submission number
- (no number) Karl Storz predicate electrode products and electrosurgical generators: named in the summary without a submission number
- (no number) ProSurge rollerballs: named in the summary without a submission number
- (no number) Karl Storz-America, Inc. rollerballs: named in the summary without a submission number

## Indications for use
The ArthroCare Monopolar Loop is indicated in patients requiring endoscopic soft tissue ablation and resection in general urological surgical procedures.

Source page: https://510kreport.com/device/K970526
Methodology: https://510kreport.com/methodology