Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm— 510(k) K192511

Substantially Equivalent

Venner Medical (Singapore) Pte, Ltd.

FDA 510(k) clearance K192511 for Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm, Substantially Equivalent on 2020-07-22. Applicant: Venner Medical (Singapore) Pte, Ltd..

Clearance details

Applicant: Venner Medical (Singapore) Pte, Ltd.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2019-09-12
Decision date: 2020-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.