SENTRY INSERTION TRAY— 510(k) K942827

Substantially Equivalent

Sentry Medical Products, Inc.

FDA 510(k) clearance K942827 for SENTRY INSERTION TRAY, Substantially Equivalent on 1994-11-02. Applicant: Sentry Medical Products, Inc..

Clearance details

Applicant: Sentry Medical Products, Inc.
Product code: Code FOS
Advisory panel: General Hospital
Date received: 1994-06-14
Decision date: 1994-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lombard, IL, US

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Adverse events under product code FOS

product code FOS

Death: 12
Other: 1
Total: 13

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.