Clearance Summary
NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL received FDA 510(k) clearance under submission number K250285, sponsored by Raumedic 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 2025-08-29.
- Submission: K250285
- Applicant / Sponsor: Raumedic AG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 2025-08-29
Classification & Regulation
This clearance is catalogued under FDA product code GWM and 21 CFR 882.1620, within the Neurology review panel as a Class II device.