Cleared Traditional

K133311 - ENDOLED

K133311 is an FDA 510(k) clearance for ENDOLED, manufactured by Olympus Winter & Ibe GmbH. The device is a Class 2 Gastroenterology & Urology device with product code NTN cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K133311 · Olympus Winter & Ibe GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
275d
Days
Class 2
Risk

K133311 is an FDA 510(k) clearance for the ENDOLED. Classified as Led Light Source (product code NTN), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Center Valley, US). The FDA issued a Cleared decision on July 30, 2014 after a review of 275 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.

FDA 510(k) Submission Details - K133311

510(k) Number K133311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2013
Decision Date July 30, 2014
Days to Decision 275 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 131d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NTN Device Classification - Class 2, Special Controls

Product Code NTN Led Light Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals
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 - NTN Led Light Source

All 8
Devices cleared under the same product code (NTN) and FDA review panel - the closest regulatory comparables to K133311.
ARTEMIS LIGHT ENGINE
K141164 · Quest Medical Imaging · Mar 2015
CLL- V1 LIGHT SOURCE
K130819 · Olympus Winter & Ibe GmbH · Jun 2013
VIDEO SYSTEM CENTER
K122831 · Olympus Medical Systems Corp. · Dec 2012
LUCEA LED SURGICAL LIGHT SYSTEM
K113679 · Maquet S.A.S. · Jan 2012
SOPRO 281
K103813 · Sopro · Mar 2011
LO-50 LED LIGHT SOURCE
K102167 · Fiberoptics Technology, Inc. · Aug 2010
K133311 · ENDOLED
Download PDF FDA Summary Olympus Winter & Ibe …