# K072478: Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD

- Pathway: 510(k) (Special)
- Applicant: Baylis Medical Co., Inc.
- Decided: Dec 19, 2007 after 106 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K031950 (2003). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031950: Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TD, Baylis Medical Co., Inc. (2003) Summary page 1.

## Most influential descendants
- K192491: Coolief Radiofrequency Generator (CRG) System (2020), 0 descendants of its own
- K181864: Polaris RF Ablation System (2019), 0 descendants of its own
- K093185: Owl Universal RF System Urf-3AP (ML) (2010), 0 descendants of its own

## Indications for use
Baylis Pain Management Generator - TD; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG-TD is to be used with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath TM and Baylis Pain Management Probes.

Source page: https://510kreport.com/device/K072478
Methodology: https://510kreport.com/methodology