510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K001588Substantially Equivalent

Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20

ArthroCare Corporation, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001588 is the FDA 510(k) clearance record for ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20, a class II device, cleared for Arthrocare Corp. on under FDA product code GXI (Probe, Radiofrequency Lesion). FDA records list 149 510(k) clearances for Arthrocare Corp., from to . As of , FDA records show no recalls naming K001588.

Clearance record

Decision date
Received
(86 days to decision)
Product code
GXI Probe, Radiofrequency Lesion
Regulation
21 CFR 882.4725
Device class
Class II
Review panel
Neurology
Applicant
Arthrocare Corp. 595 N. Pastoria Ave., Sunnyvale CA
510(k) summary
Summary
Third party review
No

Clearances, product code GXI

Trailing 12 months
2 clearances under product code GXI in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260