Cleared Special

K133554 - SURGICAL LIGHT HANDLE COVER

K133554 is an FDA 510(k) clearance for SURGICAL LIGHT HANDLE COVER, manufactured by Microtek Medical, Inc. an Ecolab Company. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Special 510(k) pathway after a 140-day FDA review.

K133554 · Microtek Medical, Inc. an Ecolab Company · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
140d
Days
Class 2
Risk

K133554 is an FDA 510(k) clearance for the SURGICAL LIGHT HANDLE COVER. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Microtek Medical, Inc. an Ecolab Company (Saint Paul, US). The FDA issued a Cleared decision on April 8, 2014 after a review of 140 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133554

510(k) Number K133554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2013
Decision Date April 08, 2014
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

FTA Device Classification - Class 2, Special Controls

Product Code FTA Light, Surgical, Accessories
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 - FTA Light, Surgical, Accessories

All 25
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K133554.
Universal Light Handle Cover, Light Handle Cover
K150532 · Key Surgical, Inc. · Sep 2015
Operating Room Light Handle Adapter
K142386 · Litex Manufacturing, Inc. · Sep 2014
IDSS SLC
K133413 · Black Diamond Video · Jan 2014
OASYS SURGICAL LIGHT CONTROLLER
K112133 · Oasys Healthcare · Mar 2012
EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
K102791 · Image Stream Medical, Inc. · Nov 2010
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
K081698 · Image Stream Medical, Inc. · Jul 2008
K133554 · SURGICAL LIGHT HANDLE COVER
Download PDF FDA Summary Microtek Medical, Inc…