Clearance Summary
METIC- Airway Balloon Catheter received FDA 510(k) clearance under submission number K231818, sponsored by M/S Meril Life Sciences Pvt. , Ltd.. 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 2023-11-15.
- Submission: K231818
- Applicant / Sponsor: M/S Meril Life Sciences Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2023-11-15
Classification & Regulation
This clearance is catalogued under FDA product code KTI and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.