FDA device listing
NEUROBLATE SYSTEM
FDA device listing 1427490518 · I-Tek Medical, Inc.
Key facts
| Proprietary names | NEUROBLATE SYSTEM |
|---|---|
| Owner/operator | I-Tek Medical, Inc. |
| Owner/operator number | 10047604 |
| Product codes | GEX, HAW |
| Device names | GEX - Powered Laser Surgical Instrument, HAW - Neurological Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810, 882.4560 |
| Review panels | General & Plastic Surgery, Neurology |
| Registered establishments | I-Tek Medical, Inc. |
| Establishment registrations | 3008627763 |
| FEI numbers | 3008627763 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database