FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIROL EPIDURAL CATHETER
K Number: K000886
·
Decision Oct 5, 2000
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
74
Applicant Total
883
Review Days
199
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Basic Information
- Device Name
- SPIROL EPIDURAL CATHETER
- K Number
- K000886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Abbott Laboratories
- Date Received
- March 20, 2000
- Decision Date
- October 5, 2000
- Product Code
- BSO
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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