Cleared Traditional

Digital ClarusScope System; Digital NeuroPEN System

K240535 · Clarus Medical, LLC · Orthopedic

Apr 2024

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K240535 is an FDA 510(k) clearance for the Digital ClarusScope System; Digital NeuroPEN System, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Clarus Medical, LLC (Minneapolis, US). The FDA issued a Cleared decision on April 25, 2024, 59 days after receiving the submission on February 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K240535 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2024
Decision Date	April 25, 2024
Days to Decision	59 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).