510(k) K881451— SIMPLEX UNIVERSAL HEATED TUBING SLEEVE

Substantially Equivalent

Simplex Medical Corp.

Clearance details

Applicant: Simplex Medical Corp.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1988-04-06
Decision date: 1988-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.