ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300— 510(k) K972878
Substantially EquivalentSafety 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.. Device class: 2.
Clearance details
- Applicant
- Safety Syringes, Inc.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arcadia, CA, US
Recent devices under product code FMF
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- K042712 — TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
- K013801 — ULTRASAFE DENTAL INJECTION SYSTEM
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, through . 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.