Cleared Traditional

K132747 - VISUM BLADE LED SURGICAL LIGHTING SYSTEM

K132747 is an FDA 510(k) clearance for VISUM BLADE LED SURGICAL LIGHTING SYSTEM, manufactured by Stryker Communications. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K132747 · Stryker Communications · General & Plastic Surgery device
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Dec 2013
Decision
118d
Days
Class 2
Risk

K132747 is an FDA 510(k) clearance for the VISUM BLADE LED SURGICAL LIGHTING SYSTEM. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Stryker Communications (Flower Mound, US). The FDA issued a Cleared decision on December 30, 2013 after a review of 118 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Communications devices

FDA 510(k) Submission Details - K132747

510(k) Number K132747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date December 30, 2013
Days to Decision 118 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 48
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K132747.
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
K140930 · Convida Healthcare & Systems Corporation · Jun 2014
MACH LED 2SC
K140460 · Dr. Mach GmbH & Co. KG · Apr 2014
MACH LED 2MC
K140461 · Dr. Mach GmbH & Co. KG · Apr 2014
VIDA LED SURGICAL LIGHTING SYSTEM
K132307 · Convida Healthcare & Systems Corporation · Nov 2013
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
K131893 · Ajw Technology Consultants, Inc. · Oct 2013
ORICARE L2700
K122875 · Oricare, Inc. · Dec 2012