Cleared Traditional

K070376 - CONMED LINVATEC 300W XENON LIGHT SOURCE

K070376 is an FDA 510(k) clearance for CONMED LINVATEC 300W XENON LIGHT SOURCE, manufactured by Conmed Linvatec. The device is a Class 2 Gastroenterology & Urology device with product code GCT cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K070376 · Conmed Linvatec · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
193d
Days
Class 2
Risk

K070376 is an FDA 510(k) clearance for the CONMED LINVATEC 300W XENON LIGHT SOURCE. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on August 20, 2007 after a review of 193 days - an extended review cycle.

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 Conmed Linvatec devices

FDA 510(k) Submission Details - K070376

510(k) Number K070376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2007
Decision Date August 20, 2007
Days to Decision 193 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 130d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCT Device Classification - Class 2, Special Controls

Product Code GCT Light Source, Endoscope, Xenon Arc
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 - GCT Light Source, Endoscope, Xenon Arc

All 21
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K070376.
XENON-100 SCB LIGHT SOURCE, MODEL 20132620
K082925 · KARL STORZ Endoscopy-America, Inc. · Dec 2008
KSEA MEDI PACK
K022490 · KARL STORZ Endoscopy-America, Inc. · Sep 2003
LINVATEC 300W XENON LIGHT SOURCE
K031994 · Linvatec Corp. · Aug 2003
LUMENON XENON LIGHT SOURCE
K992050 · Walter Lorenz Surgical, Inc. · Sep 1999
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628 · Richard Wolf Medical Instruments Corp. · Dec 1998
WELCH ALLYN XENON 300 LIGHT SOURCE
K980281 · Welch Allyn, Inc. · Feb 1998