Clearance Summary
LATERA Absorbable Nasal Implant System received FDA 510(k) clearance under submission number K192661, sponsored by Entellus Medical, Inc. (Aka Stryker Ent). The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2019-11-10.
- Submission: K192661
- Applicant / Sponsor: Entellus Medical, Inc. (Aka Stryker Ent)
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2019-11-10
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.