ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS— 510(k) K082666
Substantially EquivalentArthrocare Corp.
FDA 510(k) clearance K082666 for ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS, Substantially Equivalent on 2008-10-15. Applicant: Arthrocare Corp.. Device class: 2.
Clearance details
- Applicant
- Arthrocare Corp.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
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Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.