BD SINGLE USE, HYPODERMIC SYRINGE
FDA 510(k) clearance K110771 · decided 2011-05-13
Clearance details
- K-number
- K110771
- Device name
- BD SINGLE USE, HYPODERMIC SYRINGE
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2011-03-21
- Decision date
- 2011-05-13
- Days to decision
- 53 days
- Clearance type
- Special
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, recall (Z-2614-2026) | Mentor Texas LP | 2026-06-26 |
| BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Cata recall (Z-1055-2015) | Becton Dickinson & Company | 2015-02-05 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BD ONCLARITY HPV ASSAY (P160037/S022) | Becton, Dickinson and Company | 2025-08-25 |
| BD Onclarity HPV Assay (P160037/S023) | Becton, Dickinson and Company | 2025-07-02 |
| Onclarity HPV Assay (P160037/S021) | Becton, Dickinson and Company | 2025-03-12 |
| BD Onclarity HPV Assay (P160037/S020) | Becton, Dickinson and Company | 2024-11-05 |
| BD Onclarity HPV Assay (P160037/S017) | Becton, Dickinson and Company | 2024-05-14 |
| BD Onclarity HPV Assay (P160037/S019) | Becton, Dickinson and Company | 2024-04-18 |
| BD Onclarity HPV Assay (P160037/S018) | Becton, Dickinson and Company | 2023-11-20 |
| BD Onclarity HPV (P160037/S016) | Becton, Dickinson and Company | 2023-11-15 |