Atlas FDA

ARTHROCARE ARTHROWANDS

FDA 510(k) clearance K082980 · decided 2008-11-05

Clearance details

K-number
K082980
Device name
ARTHROCARE ARTHROWANDS
Applicant
Arthrocare Corp.
Decision
Substantially Equivalent
Date received
2008-10-06
Decision date
2008-11-05
Days to decision
30 days
Clearance type
Special
Product code
GEI
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Sunnyvale, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand recall (Z-0615-2012)Innovatech Medical Resources L.P.2012-01-11
SideWinder Hip Wand Product Number AC2340-01 is an ablation wand Intended for resection, a recall (Z-0616-2012)Innovatech Medical Resources L.P.2012-01-11
MultiVac Tristar 50 Product Number AS4630-01 is an ablation wand Intended for resection, a recall (Z-0617-2012)Innovatech Medical Resources L.P.2012-01-11
CoVac 50 Product Number AS2530-01 is an ablation wand Intended for resection, ablation, an recall (Z-0618-2012)Innovatech Medical Resources L.P.2012-01-11
CoVac 70 Product Number AS3730-01 is an ablation wand Intended for resection, ablation, an recall (Z-0619-2012)Innovatech Medical Resources L.P.2012-01-11
3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand Intended for resection, abl recall (Z-0620-2012)Innovatech Medical Resources L.P.2012-01-11
3.5mm 90 Degree Part Number A1335-01 is an ablation wand Intended for resection, ablation, recall (Z-0621-2012)Innovatech Medical Resources L.P.2012-01-11
Saber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and c recall (Z-0622-2012)Innovatech Medical Resources L.P.2012-01-11
Turbo Vac 90 with Cable Part Number ASC1335-01 is an ablation wand Indicated for resection recall (Z-0623-2012)Innovatech Medical Resources L.P.2012-01-11
Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand recall (Z-0624-2012)Innovatech Medical Resources L.P.2012-01-11
90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand Intended for resectio recall (Z-0625-2012)Innovatech Medical Resources L.P.2012-01-11
3.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection, ablati recall (Z-0626-2012)Innovatech Medical Resources L.P.2012-01-11