Cleared Traditional

K132747 - VISUM BLADE LED SURGICAL LIGHTING SYSTEM

K132747 is the FDA 510(k) clearance for VISUM BLADE LED SURGICAL LIGHTING SYSTEM by Stryker Communications. It is a Class 2 General & Plastic Surgery device (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

Submission Details

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.

Device Classification

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

Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K132747.
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation · Oct 2007
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · Stryker Endoscopy · Aug 2003
AMSCO SQ240 SURGICAL LIGHT
K943288 · American Sterilizer Co. · Oct 1994
AMSCO QUANTUM LIGHT
K896674 · American Sterilizer Co. · Jan 1990
SMITH & NEPHEW DAYLIGHTER(TM)
K873786 · Smith & Nephew, Inc. · Oct 1987
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
K820681 · Sybron Corp. · Apr 1982