Clearance Summary
nextaro® va, 15mm, 5µm received FDA 510(k) clearance under submission number K241976, sponsored by Sfm Medical Devices GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-09-06.
- Submission: K241976
- Applicant / Sponsor: Sfm Medical Devices GmbH
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2024-09-06
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.