Cleared Traditional

K974579 - PERCSCOPE MODEL 2600
(FDA 510(k) Clearance)

K974579 · Clarus Medical Systems, Inc. · Orthopedic

Feb 1998

Decision

72d

Days

Class 2

Risk

K974579 is an FDA 510(k) clearance for the PERCSCOPE MODEL 2600, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 18, 1998, 72 days after receiving the submission on December 8, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K974579 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 1997
Decision Date	February 18, 1998
Days to Decision	72 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).