Clearance Summary
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS received FDA 510(k) clearance under submission number K130736, sponsored by Helix Medical, LLC. 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 2013-12-17.
- Submission: K130736
- Applicant / Sponsor: Helix Medical, LLC
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 2013-12-17
Classification & Regulation
This clearance is catalogued under FDA product code LRC and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.