# K870028: SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Oct 26, 1987 after 294 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
No predicates in its family tree.
111 later devices descend from it; 8 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963577: Radionics Sluijter-Mehta Cannula (1996), 109 descendants of its own
- K980430: Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) (1998), 108 descendants of its own
- K021329: Rita System (2002), 76 descendants of its own
- K042216: Cool-Tip RF Ablation System (2004), 75 descendants of its own
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 56 descendants of its own

Source page: https://510kreport.com/device/K870028
Methodology: https://510kreport.com/methodology