SHARPSAFE CAT NO. 4105, 4115 AND 4120— 510(k) K942937

Substantially Equivalent

Smiths Industries Medical Systems, Inc.

FDA 510(k) clearance K942937 for SHARPSAFE CAT NO. 4105, 4115 AND 4120, Substantially Equivalent on 1994-08-25. Applicant: Smiths Industries Medical Systems, Inc..

Clearance details

Applicant: Smiths Industries Medical Systems, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1994-06-22
Decision date: 1994-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.