FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
K Number: K080282
·
Decision Feb 15, 2008
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
112
Review Days
11
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Basic Information
- Device Name
- ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
- K Number
- K080282
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrocare Corp.
- Date Received
- February 4, 2008
- Decision Date
- February 15, 2008
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Arthrocare Corp.
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|---|---|---|---|
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| K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR | Feb 27, 2013 | Substantially Equivalent |
| 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 |
| K110781 | 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP | May 27, 2011 | Substantially Equivalent |
| 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 |