Cleared Abbreviated

K003577 - STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT

K003577 is the FDA 510(k) clearance for STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT by STERIS Corporation. It is a Class 2 General & Plastic Surgery device (product code FST) cleared through the Abbreviated 510(k) pathway after a 70-day FDA review.

K003577 · STERIS Corporation · General & Plastic Surgery device
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Jan 2001
Decision
70d
Days
Class 2
Risk

K003577 is an FDA 510(k) clearance for the STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by STERIS Corporation (Montgomery, US). The FDA issued a Cleared decision on January 29, 2001 after a review of 70 days - a notably fast clearance cycle.

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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all STERIS Corporation devices

Submission Details

510(k) Number K003577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date January 29, 2001
Days to Decision 70 days
Submission Type Abbreviated
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
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FST Light, Surgical, Fiberoptic
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 - FST Light, Surgical, Fiberoptic

All 15
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K003577.
ZIMMER MIS LIGHT
K080367 · Zimmer Spine, Inc. · Feb 2008
PROXENON 350, MODEL 902XX
K071218 · Welch Allyn, Inc. · Jun 2007
NUVASIVE MAXCESS LIGHT GUIDE
K042034 · Nuvasive, Inc. · Oct 2004
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · Kirschner Medical Corp. · Aug 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · Pentax Precision Instrument Corp. · Jan 1992
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004 · Advanced Surgical Products, Inc. · Mar 1988