STERICAP ASSEMBLY AND REPLACEMENT TRAY— 510(k) K872067

Substantially Equivalent

Stericap Systems

FDA 510(k) clearance K872067 for STERICAP ASSEMBLY AND REPLACEMENT TRAY, Substantially Equivalent on 1987-08-04. Applicant: Stericap Systems.

Clearance details

Applicant: Stericap Systems
Product code: Code FMG
Advisory panel: General Hospital
Date received: 1987-05-29
Decision date: 1987-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Bern, NC, US

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Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.