Cleared Traditional

K020408 - SYSTEM 2000 CONTROLLER

K020408 is the FDA 510(k) clearance for SYSTEM 2000 CONTROLLER by Arthrocare Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K020408 · Arthrocare Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
84d
Days
Class 2
Risk

K020408 is an FDA 510(k) clearance for the SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND V.... 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 2, 2002 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrocare Corp. devices

Submission Details

510(k) Number K020408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2002
Decision Date May 02, 2002
Days to Decision 84 days
Submission Type Traditional
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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K020408.
ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K021519 · Arthrocare Corp. · Jun 2002
MODIFICATION TO ENTEC PLASMA WANDS
K021364 · Arthrocare Corp. · May 2002
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
K020579 · Aaron Medical Industries · May 2002
ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
K020919 · AtriCure, Inc. · Apr 2002
MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
K021077 · Megadyne Medical Products, Inc. · Apr 2002
COBRA COOLED SURGICAL PROBE, MODEL 1596X
K021046 · Boston Scientific Corp · Apr 2002