Cleared Traditional

REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS

K022744 · Medical Device Services · Orthopedic

Sep 2002

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K022744 is an FDA 510(k) clearance for the REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Medical Device Services (St. George, US). The FDA issued a Cleared decision on September 18, 2002, 30 days after receiving the submission on August 19, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K022744 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2002
Decision Date	September 18, 2002
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820