Cleared Traditional

K031068 - STRYKER VISUM SURGICAL LIGHTING SYSTEM

K031068 is the FDA 510(k) clearance for STRYKER VISUM SURGICAL LIGHTING SYSTEM by Stryker Endoscopy. It is a Class 2 General & Plastic Surgery device (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

Submission Details

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.

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 K031068.
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation · Oct 2007
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