Cleared Special

K013463 - ARTHROCARE ARTHRO WANDS

K013463 is the FDA 510(k) clearance for ARTHROCARE ARTHRO WANDS by Arthrocare Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 28-day FDA review.

K013463 · Arthrocare Corp. · General & Plastic Surgery device
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Nov 2001
Decision
28d
Days
Class 2
Risk

K013463 is an FDA 510(k) clearance for the ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND. 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 November 15, 2001 after a review of 28 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 K013463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2001
Decision Date November 15, 2001
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K013463.
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
K014222 · Arthrocare Corp. · Jan 2002
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
K013416 · Intuitive Surgical, Inc. · Jan 2002
REPROCESSED SOFT TISSUE ABLATORS
K012631 · Alliance Medical Corp. · Dec 2001
REPROCESSED RF ARTHROSCOPY PROBES
K012679 · Sterilmed, Inc. · Nov 2001
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
K013348 · Erbe USA, Inc. · Oct 2001
ARTHROCARE ELECTROSURGERY WANDS
K012519 · Arthrocare Corp. · Oct 2001