# K963577: Radionics Sluijter-Mehta Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Nov 21, 1996 after 76 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K870028 (1987). 1 ancestor in all.
109 later devices descend from it; 6 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870028: SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible, Radionics, Inc. (1987) Summary page 1.
- (no number) Radionics TIC Cannula: named in the summary without a submission number

## Most influential descendants
- 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
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 50 descendants of its own

## Indications for use
The RSM-C is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. This is the same intended use as the SMK Cannula and TIC Cannula.

Source page: https://510kreport.com/device/K963577
Methodology: https://510kreport.com/methodology