510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020621Substantially Equivalent

Arthrocare Controller; Arthrocare 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)

K020621 is the FDA 510(k) clearance record for ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS, a class I device, cleared for Arthrocare Corp. on under FDA product code GEY (Motor, Surgical Instrument, Ac-Powered). FDA records list 149 510(k) clearances for Arthrocare Corp., from to . As of , FDA records show no recalls naming K020621.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GEY Motor, Surgical Instrument, Ac-Powered
Regulation
21 CFR 878.4820
Device class
Class I
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 GEY

Trailing 12 months

FDA records hold no clearances under product code GEY in the trailing twelve months.

FDA records show no clearances under product code GEY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260