# K041021: RF Introduction Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Sep 16, 2004 after 149 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K870028 (1987). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980430: Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS), Radionics, Inc. (1998) Summary page 1.
- (no number) Cotop International RF Cannula: named in the summary without a submission number

## Most influential descendants
- K102566: Owl Cannulae (2011), 3 descendants of its own
- K141586: Owl Cannulae (2014), 2 descendants of its own
- K190256: Rulo Radiofrequency Lesion Probe (2019), 0 descendants of its own
- K150371: Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH (2015), 0 descendants of its own

## Recalls of this device
- Feb 21, 2020 · Class II · Z-1849-2020: Incorrect expiration date on introduction cannula packaging.
- Feb 21, 2020 · Class II · Z-1850-2020: Incorrect expiration date on introduction cannula packaging.

## Indications for use
The Epimed RF Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain

Source page: https://510kreport.com/device/K041021
Methodology: https://510kreport.com/methodology