Cleared Special

K022475 - MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS

K022475 is an FDA 510(k) clearance for MODIFICATION TO ARTHROCARE CONTROLLER (..., manufactured by Arthrocare Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 66-day FDA review.

K022475 · Arthrocare Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
66d
Days
Class 2
Risk

K022475 is an FDA 510(k) clearance for the MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATI.... 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 October 3, 2002 after a review of 66 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

FDA 510(k) Submission Details - K022475

510(k) Number K022475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date October 03, 2002
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

GEI Device Classification - Class 2, Special Controls

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 1747
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K022475.
THERMAGE THERMACOOL TC SYSTEM
K021402 · Thermage, Inc. · Nov 2002
AUTOCON II 400 ELECTROSURGICAL GENERATOR
K021467 · KARL STORZ Endoscopy-America, Inc. · Nov 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · Boston Scientific Corp · Oct 2002
PRECISION PLUS TUNA OFFICE SYSTEM
K021804 · Medtronic Vascular · Aug 2002
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
K021777 · Gyrus Ent LLC · Aug 2002
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
K012018 · Acmi Corporation · Jul 2002