Cleared Traditional

REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS

K012676 · Adven Medical · Orthopedic

Feb 2002

Decision

174d

Days

Class 1

Risk

About This 510(k) Submission

K012676 is an FDA 510(k) clearance for the REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Adven Medical (Lubbock, US). The FDA issued a Cleared decision on February 4, 2002, 174 days after receiving the submission on August 14, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K012676 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2001
Decision Date	February 04, 2002
Days to Decision	174 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