Cleared Special

K133554 - SURGICAL LIGHT HANDLE COVER (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K133554 · Microtek Medical, Inc. an Ecolab Company · General & Plastic Surgery device
Download Printable Device Report (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.

View all Microtek Medical, Inc. an Ecolab Company devices

Submission Details

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
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 114d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.