FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUOHY EPIDURAL NEEDLES
K Number: K961152
·
Decision Mar 19, 1997
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
3
Review Days
362
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Basic Information
- Device Name
- TUOHY EPIDURAL NEEDLES
- K Number
- K961152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hakko Shoji Co., Ltd.
- Date Received
- March 22, 1996
- Decision Date
- March 19, 1997
- 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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