FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K Number: K081446
·
Decision Jul 17, 2008
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
190
Review Days
56
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Basic Information
- Device Name
- BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
- K Number
- K081446
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson & CO
- Date Received
- May 22, 2008
- Decision Date
- July 17, 2008
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
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