Cleared Traditional

K031068 - STRYKER VISUM SURGICAL LIGHTING SYSTEM

K031068 is an FDA 510(k) clearance for STRYKER VISUM SURGICAL LIGHTING SYSTEM, manufactured by Stryker Endoscopy. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K031068 · Stryker Endoscopy · General & Plastic Surgery device
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Aug 2003
Decision
130d
Days
Class 2
Risk

K031068 is an FDA 510(k) clearance for the STRYKER VISUM SURGICAL LIGHTING SYSTEM. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on August 12, 2003 after a review of 130 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 Endoscopy devices

FDA 510(k) Submission Details - K031068

510(k) Number K031068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date August 12, 2003
Days to Decision 130 days
Submission Type Traditional
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
15d slower than avg
Panel avg: 115d · This submission: 130d
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 K031068.
AURORA LED SERIES SURGICAL LIGHTS
K071698 · Skytron, Div. the Kmw Group, Inc. · Jul 2007
OUTPATIENT III MINOR SURGERY LIGHT
K042395 · Burton Medical Products Corp. · Dec 2004
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
K042382 · Med-General Technologies, LLC · Nov 2004
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