Clearance Summary
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 received FDA 510(k) clearance under submission number K243698, sponsored by Brainlab AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-01-28.
- Submission: K243698
- Applicant / Sponsor: Brainlab AG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2025-01-28
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.