510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K962445Substantially Equivalent

Arthrocare Dental Electrosurgery System

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

K962445 is the FDA 510(k) clearance record for ARTHROCARE DENTAL ELECTROSURGERY SYSTEM, a class II device, cleared for Arthrocare Corp. on under FDA product code EKZ (Unit, Electrosurgical, And Accessories, Dental). FDA records list 149 510(k) clearances for Arthrocare Corp., from to . As of , FDA records show no recalls naming K962445.

Clearance record

Decision date
Received
(36 days to decision)
Product code
EKZ Unit, Electrosurgical, And Accessories, Dental
Regulation
21 CFR 872.4920
Device class
Class II
Review panel
Dental
Applicant
Arthrocare Corp. 595 N. Pastoria Ave., Sunnyvale CA
510(k) summary
Summary
Third party review
No

Clearances, product code EKZ

Trailing 12 months

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

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