Cleared Traditional

POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES

K080617 · Richard Wolf Medical Instruments Corp. · Orthopedic

Jun 2008

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K080617 is an FDA 510(k) clearance for the POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on June 27, 2008, 115 days after receiving the submission on March 4, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K080617 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2008
Decision Date	June 27, 2008
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).