FDA device listing
Alignment Guide Tube Cranial 2.5/7.5,Alignment Guide Tube Cranial 3.8/7.5,Alignment Guide Tube Cranial 4.0/7.5,Alignment…
FDA device listing 1847166749 · Brainlab SE
Key facts
| Proprietary names | Alignment Guide Tube Cranial 2.5/7.5,Alignment Guide Tube Cranial 3.8/7.5,Alignment Guide Tube Cranial 4.0/7.5,Alignment Reduction Tube Cranial 2.5/4.0,Alignment Software Cranial,Alignment System Cranial,AUTO-REG MATRIX IMRI,Cirq Alignment Software Cranial Biopsy,Cirq Alignment Software Cranial sEEG,Cirq Robotic Disposable Kinematic Unit,Cirq Robotic Instrument Holder Cranial,Cirq Robotic Tracking… |
|---|---|
| Owner/operator | Brainlab SE |
| Owner/operator number | 9004547 |
| Premarket submissions | K223864 |
| Product codes | HAW |
| Device names | HAW - Neurological Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560 |
| Review panels | Neurology |
| Registered establishments | BRAINLAB SE |
| Establishment registrations | 8043933 |
| FEI numbers | 3002619595 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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