Clearance Summary
PuraSinus received FDA 510(k) clearance under submission number K183015, sponsored by 3-D Matrix, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2019-04-12.
- Submission: K183015
- Applicant / Sponsor: 3-D Matrix, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2019-04-12
Classification & Regulation
This clearance is catalogued under FDA product code NHB and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.