FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
K Number: K020621
·
Decision Mar 28, 2002
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
112
Review Days
30
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Basic Information
- Device Name
- ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
- K Number
- K020621
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrocare Corp.
- Date Received
- February 26, 2002
- Decision Date
- March 28, 2002
- Product Code
- GEY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Arthrocare Corp.
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|---|---|---|---|
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| K111399 | SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 | Jul 20, 2011 | Substantially Equivalent |
| K111397 | TITAN TI SUTURE ANCHOR SYSTEM | Jul 12, 2011 | Substantially Equivalent |
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| K110183 | ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Feb 16, 2011 | Substantially Equivalent |
| K110164 | 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL | Feb 7, 2011 | Substantially Equivalent |
| K101437 | SPEEDFIX SUTURE SYSTEM | Oct 29, 2010 | Substantially Equivalent |
| K102262 | ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL | Oct 21, 2010 | Substantially Equivalent |