FDA product code LGW: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

LGW is the FDA product code for stimulator, spinal-cord, totally implanted for pain relief. It is a Class III device, reviewed by the Neurology panel. Devices under LGW reach the market by PMA; FDA lists no cleared 510(k)s for it. 8 PMA applications cite this product code. FDA has posted 96 recalls for LGW devices, 41 initiated in the last five years.

Classification

Recalls for LGW devices

96 product recalls in 60 recall events; 41 initiated in the last five years and 44 still open. Most recent: 2026-06-17.

Frequently asked questions

What is FDA product code LGW?

LGW is the FDA product code for stimulator, spinal-cord, totally implanted for pain relief. It is a Class III device, reviewed by the Neurology panel.

What device class is LGW?

Class III. Typical premarket route: PMA.

Have LGW devices been recalled?

Yes: 96 product recalls across 60 recall events; the most recent began 2026-06-17.

Next steps

• Run an FDA pathway report with predicate devices for product code LGW
• Run a recall and safety report across every LGW manufacturer
• Watch product code LGW for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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