FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K Number: K001588
·
Decision Aug 17, 2000
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
65
Applicant Total
112
Review Days
86
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Basic Information
- Device Name
- ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
- K Number
- K001588
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrocare Corp.
- Date Received
- May 23, 2000
- Decision Date
- August 17, 2000
- Product Code
- GXI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | FDA class 2 | Neurology |
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