SOFTECH Plus ETCO2 Cannula— 510(k) K143469

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K143469 for SOFTECH Plus ETCO2 Cannula, Substantially Equivalent on 2015-02-12. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2014-12-05
Decision date: 2015-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.