Cleared Traditional

ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)

K083161 · Conmed Linvatec · Orthopedic

Mar 2009

Decision

151d

Days

Class 2

Risk

About This 510(k) Submission

K083161 is an FDA 510(k) clearance for the ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100), a Arthroscope (Class II — Special Controls, product code HRX), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on March 27, 2009, 151 days after receiving the submission on October 27, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K083161 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2008
Decision Date	March 27, 2009
Days to Decision	151 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).