FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K Number: K011122
·
Decision Nov 16, 2001
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
151
Applicant Total
43
Review Days
218
Basic Information
- Device Name
- BALLPEN SPINAL NEEDLE W/WO INTRODUCER
- K Number
- K011122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RUSCH INTL.
- Date Received
- April 12, 2001
- Decision Date
- November 16, 2001
- 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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