# K101372: Duocool Pain Management Probe, Model Osp-17-180-20

- Pathway: 510(k) (Special)
- Applicant: Baylis Medical Co., Inc.
- Decided: Aug 10, 2010 after 85 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
Longest line of descent: 2 generations back to K972846 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092337: Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS, Baylis Medical Co., Inc. (2009) Summary page 1.

## Indications for use
The DuoCool Pain Management Probe (probe model number: OSP-17-150-20; kit model number: OSK-i17-180-20) is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain

Source page: https://510kreport.com/device/K101372
Methodology: https://510kreport.com/methodology