Clearance Summary
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS received FDA 510(k) clearance under submission number K991587, sponsored by Helix Medical, 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 1999-06-25.
- Submission: K991587
- Applicant / Sponsor: Helix Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3730
- Decision date: 1999-06-25
Classification & Regulation
This clearance is catalogued under FDA product code EWL and 21 CFR 874.3730, within the Ear, Nose, Throat review panel as a Class II device.