ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300— 510(k) K972878

Substantially Equivalent

Safety Syringes, Inc.

FDA 510(k) clearance K972878 for ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300, Substantially Equivalent on 1997-10-30. Applicant: Safety Syringes, Inc..

Clearance details

Applicant: Safety Syringes, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1997-08-04
Decision date: 1997-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arcadia, CA, 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.