Cleared Special

K111020 - ATRICURE DISSECTOR

K111020 is the FDA 510(k) clearance for ATRICURE DISSECTOR by AtriCure, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTD) cleared through the Special 510(k) pathway after a 58-day FDA review.

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

K111020 is an FDA 510(k) clearance for the ATRICURE DISSECTOR. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on June 9, 2011 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K111020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FTD Lamp, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTD Lamp, Surgical

All 9
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K111020.
STRYKER KNIFELIGHT
K100884 · Howmedica Osteonics Corp. · Jun 2010
ATRICURE DISSECTOR
K041681 · AtriCure, Inc. · Jul 2004
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · STERIS Corporation · Dec 2001
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · Stryker Instruments · Jun 1998
STRYKER KNIFELIGHT
K961122 · Stryker Instruments · Aug 1996
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675 · Medline Industries, Inc. · Feb 1994