Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff— 510(k) K193077

Clearance details

Applicant

Covidien

Product code

Code JOH

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

2019-11-05

Decision date

2020-06-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Boulder, CO, US

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• K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube2019-03-22

• K241486 — Sofsilk Coated Braided Silk Suture2024-12-03
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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 →