# K090955: Smith & Nephew RF Cannulate

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 16, 2009 after 101 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K870028 (1987). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063467: Smith & Nephew RF Cannulae, Smith & Nephew, Inc. (2006) Summary page 1.

## Most influential descendants
- K253907: Disposable Radiofrequency Cannula (2026), 0 descendants of its own

## Recalls of this device
- Nov 11, 2019 · Class II · Z-0720-2020: A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.

## Indications for use
Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

Source page: https://510kreport.com/device/K090955
Methodology: https://510kreport.com/methodology