# K253907: Disposable Radiofrequency Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Apr 16, 2026 after 132 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K870028 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090955: Smith & Nephew RF Cannulate, Smith & Nephew, Inc. (2009) Summary page 5.
- K000073: Mercury Medical Disposable Radiofrequency Cannula, Mercury Medical (2000) Summary page 5.
- K042375: SMK, CX, Cxe, RCN, Technomed Europe (2004) Summary page 5.

## Indications for use
The Disposable Radiofrequency Cannulas, in combination with approved compatible generators and electrodes, are indicated as an aid in the management of pain in the peripheral nervous system. Examples include facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures. These are single-use-only products.

Source page: https://510kreport.com/device/K253907
Methodology: https://510kreport.com/methodology