510(k) K812302 ยท JOH Tube Tracheostomy And Tube Cuff
SHILEY FENESTRATED LOW PRESS. CUFFED
| Applicant | Shiley, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 8, 1981 |
| Received | Aug 14, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2026 | Covidien LLC COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN
UDI-DI code: 60884522007028
The devices are intended for use in providing tracheal access for airway management. Shiley Tracheost Open, Classified |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.