Clearance Summary
MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES received FDA 510(k) clearance under submission number K142022, sponsored by Medline Renewal. 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 2014-12-19.
- Submission: K142022
- Applicant / Sponsor: Medline Renewal
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4140
- Decision date: 2014-12-19
Classification & Regulation
This clearance is catalogued under FDA product code NLY and 21 CFR 874.4140, within the Ear, Nose, Throat review panel as a Class I device.