510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K082666Substantially Equivalent

Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power Cord, Wands

ArthroCare Corporation, Sunnyvale CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082666 is the FDA 510(k) clearance record for ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS, a class II device, cleared for Arthrocare Corp. on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "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...". FDA records list 149 510(k) clearances for Arthrocare Corp., from to . As of , FDA records show no recalls naming K082666.

Clearance record

Decision date
Received
(33 days to decision)
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Arthrocare Corp. 680 Vaqueros Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEI

Trailing 12 months
44 clearances under product code GEI in the twelve months to November 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20261
November 20260