BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.— 510(k) K930105

Substantially Equivalent

Helix Medical, Inc.

FDA 510(k) clearance K930105 for BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S., Substantially Equivalent on 1993-05-17. Applicant: Helix Medical, Inc..

Clearance details

Applicant: Helix Medical, Inc.
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 1993-01-11
Decision date: 1993-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbera, CA, US

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Adverse events under product code EWL

product code EWL

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.