Cleared Special

ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS

K020621 · Arthrocare Corp. · General & Plastic Surgery
Mar 2002
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K020621 is an FDA 510(k) clearance for the ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS, a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on March 28, 2002, 30 days after receiving the submission on February 26, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K020621 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2002
Decision Date March 28, 2002
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEY — Motor, Surgical Instrument, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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