BD INTEGRA SYRINGE
FDA 510(k) clearance K023752 · decided 2003-02-07
Clearance details
- K-number
- K023752
- Device name
- BD INTEGRA SYRINGE
- Applicant
- Bd
- Decision
- Substantially Equivalent
- Date received
- 2002-11-08
- Decision date
- 2003-02-07
- Days to decision
- 91 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Bd
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x recall (Z-0619-2009) | Becton Dickinson & Company | 2009-01-13 |
| BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2'' (0.33 recall (Z-0582-2007) | Becton Dickinson & Company | 2007-03-03 |