AIRE-CUF TRACHEOSTOMY TUBE— 510(k) K812163

Substantially Equivalent

Bioana Surgical Instruments, Inc.

FDA 510(k) clearance K812163 for AIRE-CUF TRACHEOSTOMY TUBE, Substantially Equivalent on 1981-09-21. Applicant: Bioana Surgical Instruments, Inc..

Clearance details

Applicant: Bioana Surgical Instruments, Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 1981-07-29
Decision date: 1981-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.