Cleared Special

K031979 - CONMED INTEGRATED SYSTEMS NURSES ASSISTANT

K031979 is an FDA 510(k) clearance for CONMED INTEGRATED SYSTEMS NURSES ASSISTANT, manufactured by Conmed Integrated Systems (Cmis). The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Special 510(k) pathway after a 29-day FDA review.

K031979 · Conmed Integrated Systems (Cmis) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
29d
Days
Class 2
Risk

K031979 is an FDA 510(k) clearance for the CONMED INTEGRATED SYSTEMS NURSES ASSISTANT. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Conmed Integrated Systems (Cmis) (Beaverton, US). The FDA issued a Cleared decision on July 25, 2003 after a review of 29 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 Conmed Integrated Systems (Cmis) devices

FDA 510(k) Submission Details - K031979

510(k) Number K031979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2003
Decision Date July 25, 2003
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
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 - FSY Light, Surgical, Ceiling Mounted

All 30
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K031979.
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation · Oct 2007
AURORA LED SERIES SURGICAL LIGHTS
K071698 · Skytron, Div. the Kmw Group, Inc. · Jul 2007
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · Stryker Endoscopy · Aug 2003
CHROMOPHARE X 65
K024132 · Berchtold Holding GmbH · Mar 2003
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
K021585 · Skytron, Div. the Kmw Group, Inc. · Nov 2002
STELLAR
K002463 · Skytron, Div. the Kmw Group, Inc. · Nov 2000