PENCIL POINT SPINAL NEEDLE AND TRAY
FDA 510(k) clearance K932569 · decided 1994-01-26
Clearance details
- K-number
- K932569
- Device name
- PENCIL POINT SPINAL NEEDLE AND TRAY
- Applicant
- B. Braun of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-27
- Decision date
- 1994-01-26
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of a recall (Z-1666-2014) | B. Braun Medical, Inc. | 2014-05-28 |
| Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampul recall (Z-1440-04) | B. Braun Medical, Inc. | 2004-09-09 |