# K032601: Stryker Interventional Pain RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Valley Forge Scientific Corp.
- Decided: Apr 1, 2004 after 220 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Oratec: named in the summary without a submission number
- (no number) Radionics: named in the summary without a submission number
- (no number) Baylis: named in the summary without a submission number
- (no number) NeuroTherm: named in the summary without a submission number
- (no number) Arthrocare: named in the summary without a submission number

## Most influential descendants
- K043442: Stryker RF Coaxial Bipolar Electrodes & Cannulae (2005), 17 descendants of its own
- K153272: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (2016), 7 descendants of its own
- K071482: Stryker RF Multi-Lesion Generator, Model 0406-900-000 (2007), 5 descendants of its own
- K061660: Stryker RF Parallel Bipolar Adaptor Cable (2006), 5 descendants of its own
- K180369: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (2018), 4 descendants of its own

## Recalls of this device
- Apr 13, 2010 · Not classified · Z-0915-2011: This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time t

## Indications for use
The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical application's. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia, and Rhizotomy.

Source page: https://510kreport.com/device/K032601
Methodology: https://510kreport.com/methodology