BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS— 510(k) K991587

Substantially Equivalent

Helix Medical, Inc.

FDA 510(k) clearance K991587 for BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS, Substantially Equivalent on 1999-06-25. Applicant: Helix Medical, Inc..

Clearance details

Applicant: Helix Medical, Inc.
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 1999-05-07
Decision date: 1999-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, 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.