Cleared Traditional

K012265 - METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088

K012265 is an FDA 510(k) clearance for METAL HALIDE LIGHT SOURCE, manufactured by Circon Video. The device is a Class 2 Gastroenterology & Urology device with product code FCW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K012265 · Circon Video · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
90d
Days
Class 2
Risk

K012265 is an FDA 510(k) clearance for the METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Circon Video (Santa Barbara, US). The FDA issued a Cleared decision on October 17, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Circon Video devices

FDA 510(k) Submission Details - K012265

510(k) Number K012265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2001
Decision Date October 17, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCW Device Classification - Class 2, Special Controls

Product Code FCW Light Source, Fiberoptic, Routine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCW Light Source, Fiberoptic, Routine

All 23
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K012265.
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968 · KARL STORZ Endoscopy-America, Inc. · Sep 2009
STRYKER LED LIGHTSOURCE
K082813 · Stryker Corp. · Dec 2008
LUXTEC MLX LIGHT SOURCE
K081477 · Integra Luxtec, Inc. · Jun 2008
COLDLIGHTSOURCE PL3000
K993300 · Fiber Imaging Technologies, Inc. · Nov 1999
50 W METAL HALIDE ILLUMINATOR, VES 0501.
K992447 · Angiolaz, Inc. · Oct 1999
INTEGRATED VISUALIZATION SYSTEM
K970598 · Urohealth, Inc. · Mar 1997