MONOJECT(R) 6 CC SAFETY SYRINGE— 510(k) K924511

Substantially Equivalent

Sherwood Medical Co.

FDA 510(k) clearance K924511 for MONOJECT(R) 6 CC SAFETY SYRINGE, Substantially Equivalent on 1993-07-29. Applicant: Sherwood Medical Co..

Clearance details

Applicant: Sherwood Medical Co.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1992-09-04
Decision date: 1993-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.