BD INSULIN SYRINGE
FDA 510(k) clearance K024112 · decided 2003-01-09
Clearance details
- K-number
- K024112
- Device name
- BD INSULIN SYRINGE
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2002-12-13
- Decision date
- 2003-01-09
- Days to decision
- 27 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 |
|---|---|---|
| BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF 328466 BD recall (Z-0183-2018) | Becton Dickinson & Company | 2017-11-28 |
| 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 00399 recall (Z-0174-2012) | Becton Dickinson & Company | 2011-11-07 |
| ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneou recall (Z-1226-2007) | Becton Dickinson & Company | 2007-09-20 |