K920090

Substantially Equivalent

BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET

Applicant: Helix Medical, Inc.
Product code: EWL
Advisory panel: Ear, Nose, Throat
Date received: 1992-01-08
Decision date: 1992-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbera, CA, US

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.