Cleared Traditional

K040919 - NUCLEOTOME PROBE SET, MODEL 21200
(FDA 510(k) Clearance)

K040919 · Clarus Medical, LLC · Orthopedic

Jun 2004

Decision

54d

Days

Class 2

Risk

K040919 is an FDA 510(k) clearance for the NUCLEOTOME PROBE SET, MODEL 21200, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Clarus Medical, LLC (Minneapolis, US). The FDA issued a Cleared decision on June 1, 2004, 54 days after receiving the submission on April 8, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K040919 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2004
Decision Date	June 01, 2004
Days to Decision	54 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).