SHARPSAFE CAT. NO. 4127— 510(k) K935628

Substantially Equivalent

Smiths Industries Medical Systems, Inc.

FDA 510(k) clearance K935628 for SHARPSAFE CAT. NO. 4127, Substantially Equivalent on 1994-02-04. Applicant: Smiths Industries Medical Systems, Inc..

Clearance details

Applicant: Smiths Industries Medical Systems, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1993-11-23
Decision date: 1994-02-04
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.