Cleared Special

ATRICURE DISSECTOR

K111020 · AtriCure, Inc. · General & Plastic Surgery
Jun 2011
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K111020 is an FDA 510(k) clearance for the ATRICURE DISSECTOR, a Lamp, Surgical (Class II — Special Controls, product code FTD), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on June 9, 2011, 58 days after receiving the submission on April 12, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K111020 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2011
Decision Date June 09, 2011
Days to Decision 58 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTD — Lamp, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

Similar Devices — FTD Lamp, Surgical

All 28
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
K133425 · Engineered Medical Solutions Co., LLC · Dec 2013
VOLISTA 400; VOLISTA 600
K130513 · Maquet S.A.S. · May 2013
POLARIS 100/200
K123776 · Drager Medical GmbH · Mar 2013
HM-LAMP II
K100234 · Hillusa, Inc. · Jul 2010
STRYKER KNIFELIGHT
K100884 · Howmedica Osteonics Corp. · Jun 2010
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
K071180 · Engineered Medical Solutions Co., LLC · Jun 2007