Cleared Traditional

CLARUS PHOENIX ENDOSCOPE

K940144 · Clarus Medical Systems, Inc. · Orthopedic

Apr 1995

Decision

469d

Days

Class 2

Risk

About This 510(k) Submission

K940144 is an FDA 510(k) clearance for the CLARUS PHOENIX ENDOSCOPE, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 25, 1995, 469 days after receiving the submission on January 11, 1994. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K940144 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1994
Decision Date	April 25, 1995
Days to Decision	469 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).