Cleared Traditional

SOPRO 670 ARTHROSCOPIC PUMP

K080122 · Sopro · Orthopedic

Jul 2008

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K080122 is an FDA 510(k) clearance for the SOPRO 670 ARTHROSCOPIC PUMP, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Sopro (Mt. Laurel, US). The FDA issued a Cleared decision on July 11, 2008, 176 days after receiving the submission on January 17, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K080122 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2008
Decision Date	July 11, 2008
Days to Decision	176 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).