ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)— 510(k) K011369
Substantially EquivalentSafety Syringes, Inc.
FDA 510(k) clearance K011369 for ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY), Substantially Equivalent on 2001-05-29. Applicant: Safety Syringes, Inc.. Device class: 2.
Clearance details
- Applicant
- Safety Syringes, Inc.
- Product code
- Code MEG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code MEG
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- K042712 — TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
- K013801 — ULTRASAFE DENTAL INJECTION SYSTEM
Adverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
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.