ARTHROCARE ENT PLASMA WAND— 510(k) K070374
Substantially EquivalentArthrocare Corp.
FDA 510(k) clearance K070374 for ARTHROCARE ENT PLASMA WAND, Substantially Equivalent on 2007-04-25. 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
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code GEI
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view all- K153186 — Adjustable Fixation Device
- K131709 — SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
- K130196 — SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
- K111399 — SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
- K111397 — TITAN TI SUTURE ANCHOR SYSTEM
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 →
Recalls naming K070374
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070374.
Data sourced from openFDA. This site is unofficial and independent of the FDA.