Clearance Summary
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET received FDA 510(k) clearance under submission number K932163, 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 1993-12-15.
- Submission: K932163
- 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: 1993-12-15
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.