Cleared Special

K061259 - MODIFICATION TO ARTHROCARE PERC-D SPINE...

K061259 is the FDA 510(k) clearance for MODIFICATION TO ARTHROCARE PERC-D SPINE... by Arthrocare Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 13-day FDA review.

K061259 · Arthrocare Corp. · General & Plastic Surgery device
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May 2006
Decision
13d
Days
Class 2
Risk

K061259 is an FDA 510(k) clearance for the MODIFICATION TO ARTHROCARE PERC-D SPINEWAND. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on May 18, 2006 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arthrocare Corp. devices

Submission Details

510(k) Number K061259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2006
Decision Date May 18, 2006
Days to Decision 13 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

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