# K062937: Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-Ppu

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Jan 8, 2007 after 102 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: 2 generations back to K002389 (2000). 3 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K031951: Transdiscal System (Transdiscal Probe), Model TDP-17-150-6, Baylis Medical Co., Inc. (2003) Summary page 1.
- K053082: Baylis Pain Management Cooled Probe, Model PMPC-18-150-6, Baylis Medical Co., Inc. (2005) Summary page 1.

## Most influential descendants
- K163236: COOLIEF Cooled Radiofrequency Kit (2016), 1 descendant of its own
- K203066: COOLIEF Cooled Radiofrequency Kit Advanced (2020), 0 descendants of its own
- K181864: Polaris RF Ablation System (2019), 0 descendants of its own

## Recalls of this device
- May 12, 2010 · Not classified · Z-1755-2010: Name of the device reflected on the product packing sleeve is incorrect.

## Indications for use
The Baylis TransDiscal System, used in combination with the Baylis Pain Management Generator, is intended for the creation of Radio Frequency (RF) lesions in nervous tissue including that which is situated in intervertebral disc material.

Source page: https://510kreport.com/device/K062937
Methodology: https://510kreport.com/methodology