Cleared Special

K020622 - ARTHROCARE CONTROLLER (SYSTEM 2000 AND ...

Also marketed or referenced as:
ARTHROCARE CABLE FOOT CONTROL POWER CORD AND WANDS

K020622 is the FDA 510(k) clearance for ARTHROCARE CONTROLLER (SYSTEM 2000 AND ... by Arthrocare Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 30-day FDA review.

K020622 · Arthrocare Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
30d
Days
Class 2
Risk

K020622 is an FDA 510(k) clearance for the ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000). 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 March 28, 2002 after a review of 30 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 K020622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2002
Decision Date March 28, 2002
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 K020622.
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K020832 · Arthrocare Corp. · Apr 2002
RESECTION ABLATOR
K013369 · Linvatec Corp. · Apr 2002
ENTEC PLASMA WANDS
K014290 · Arthrocare Corp. · Mar 2002
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · Aesculap, Inc. · Mar 2002
ARTHROCARE CONTROLLER
K020557 · Arthrocare Corp. · Mar 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · Aesculap, Inc. · Mar 2002