FDA product code LHG: Electrode, Spinal Epidural
LHG is the FDA product code for electrode, spinal epidural. It is a Class II device, regulated under 21 CFR 882.5880 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under LHG. The average 510(k) review took 113 days (median 113).
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Spinal Epidural |
| Device class | Class II |
| Regulation | 21 CFR 882.5880 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LHG clearance
Top LHG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| St Jude Medical | 1 | 2011-06-24 |
Most recent LHG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110609 | St Jude Medical | EPIDUCER LEAD DELIVERY SYSTEM | 2011-06-24 | 113 |
Recalls for LHG devices
openFDA lists no recalls for product code LHG.
Frequently asked questions
What is FDA product code LHG?
LHG is the FDA product code for electrode, spinal epidural. It is a Class II device, regulated under 21 CFR 882.5880 and reviewed by the Neurology panel.
What device class is LHG?
Class II, regulation 21 CFR 882.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code LHG?
Across 1 cleared submissions the average was 113 days from receipt to decision (median 113).
Which companies have the most LHG clearances?
St Jude Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LHG
- Run a recall and safety report across every LHG manufacturer
- Watch product code LHG 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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