BLOM-SINGER INDWELLING TEP OCCLUDER— 510(k) K093258
Substantially EquivalentHelix Medical, LLC
FDA 510(k) clearance K093258 for BLOM-SINGER INDWELLING TEP OCCLUDER, Substantially Equivalent on 2010-03-03. Applicant: Helix Medical, LLC.
Clearance details
- Applicant
- Helix Medical, LLC
- Product code
- Code EWL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Carpinteria, CA, US
Adverse events under product code EWL
product code EWL- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.