FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RK EPIDURAL NEEDLE
K Number: K072005
·
Decision Feb 7, 2008
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
2
Review Days
199
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Basic Information
- Device Name
- RK EPIDURAL NEEDLE
- K Number
- K072005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Epimed International
- Date Received
- July 23, 2007
- Decision Date
- February 7, 2008
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
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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|---|---|---|---|
| K232632 | Racz Neurostat RF Generator | May 24, 2024 | Substantially Equivalent |