BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES— 510(k) K082206

Name: FDA 510(k) clearance K082206
Creator: U.S. Food and Drug Administration
Published: 2008-09-04

Substantially Equivalent

Helix Medical, LLC

FDA 510(k) clearance K082206 for BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES, Substantially Equivalent on 2008-09-04. Applicant: Helix Medical, LLC. Device class: 2.

Clearance details

Applicant: Helix Medical, LLC
Product code: Code EWL
Device class: Class 2
Regulation: 21 CFR 874.3730
Advisory panel: Ear, Nose, Throat
Date received: 2008-08-05
Decision date: 2008-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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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.