Cleared Traditional

K080809 - IEC MEDSIGHT AND MEDBRIGHT

K080809 is an FDA 510(k) clearance for IEC MEDSIGHT AND MEDBRIGHT, manufactured by Innovative Endoscopy Components, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K080809 · Innovative Endoscopy Components, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
143d
Days
Class 2
Risk

K080809 is an FDA 510(k) clearance for the IEC MEDSIGHT AND MEDBRIGHT. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Innovative Endoscopy Components, LLC (Ft. Lauderdale, US). The FDA issued a Cleared decision on August 11, 2008 after a review of 143 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 Innovative Endoscopy Components, LLC devices

FDA 510(k) Submission Details - K080809

510(k) Number K080809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2008
Decision Date August 11, 2008
Days to Decision 143 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
13d slower than avg
Panel avg: 130d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 58
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K080809.
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
K102466 · Fujinon, Inc. · May 2011
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
K102059 · Olympus Medical Systems Corporation · Oct 2010
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K083155 · Olympus Medical Systems Corporation · Jan 2009
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
K070716 · KARL STORZ Endoscopy-America, Inc. · May 2007
AIDA WITH DICOM AND HL7 INTERFACE
K043324 · KARL STORZ Endoscopy-America, Inc. · Apr 2005
KSEA OPSERVER LAP
K031895 · KARL STORZ Endoscopy-America, Inc. · Sep 2003