Cleared Special

CONMED LINVATEC SMART GUARD IRRIGATOR

K070233 · Conmed Linvatec · Orthopedic

Apr 2007

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K070233 is an FDA 510(k) clearance for the CONMED LINVATEC SMART GUARD IRRIGATOR, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on April 2, 2007, 67 days after receiving the submission on January 25, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K070233 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2007
Decision Date	April 02, 2007
Days to Decision	67 days
Submission Type	Special
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).