SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA— 510(k) K051416

Clearance details

Applicant

Mallinckrodt Medical

Product code

Code JOH

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

2005-06-01

Decision date

2005-06-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Pleasanton, CA, US

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• K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA)1997-03-28

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 →