510(k) K130736— BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS

Substantially Equivalent

Helix Medical, LLC

Clearance details

Applicant: Helix Medical, LLC
Product code: Code LRC
Advisory panel: Ear, Nose, Throat
Date received: 2013-03-18
Decision date: 2013-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

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.