3-DAY BIOINDICATOR RELEASE FOR STERIL— 510(k) K833831

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K833831 for 3-DAY BIOINDICATOR RELEASE FOR STERIL, Substantially Equivalent on 1984-03-21. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1983-11-07
Decision date: 1984-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.