SHILEY FENESTRATED LOW PRESS. CUFFED— 510(k) K812302

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K812302 for SHILEY FENESTRATED LOW PRESS. CUFFED, Substantially Equivalent on 1981-09-08. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 1981-08-14
Decision date: 1981-09-08
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.