Alignment System Cranial, with Alignment Software Cranial with LITT +4 more— 510(k) K243698
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K243698 for Alignment System Cranial, with Alignment Software Cranial with LITT +4 more, Substantially Equivalent on 2025-01-28. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Device name as filed
- Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
- Applicant
- Brainlab AG
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Recent devices under product code HAW
view allMore clearances from Brainlab AG
view allAdverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.