BKMI DISPOSABLE SYRINGE— 510(k) K971487

Substantially Equivalent

Sumi Salud C.A.

FDA 510(k) clearance K971487 for BKMI DISPOSABLE SYRINGE, Substantially Equivalent on 1997-09-04. Applicant: Sumi Salud C.A..

Clearance details

Applicant: Sumi Salud C.A.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1997-04-23
Decision date: 1997-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Front Royal, VA, 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.