Cleared Traditional

K133538 - VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS ...

K133538 is an FDA 510(k) clearance for VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS ..., manufactured by Olympus Corporation of the Americas. The device is a Class 2 Gastroenterology & Urology device with product code NWB cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K133538 · Olympus Corporation of the Americas · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
262d
Days
Class 2
Risk

K133538 is an FDA 510(k) clearance for the VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEO.... Classified as Endoscope, Accessories, Narrow Band Spectrum (product code NWB), Class II - Special Controls.

Submitted by Olympus Corporation of the Americas (Center Valley, US). The FDA issued a Cleared decision on August 7, 2014 after a review of 262 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 Olympus Corporation of the Americas devices

FDA 510(k) Submission Details - K133538

510(k) Number K133538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2013
Decision Date August 07, 2014
Days to Decision 262 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
132d slower than avg
Panel avg: 130d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NWB Device Classification - Class 2, Special Controls

Product Code NWB Endoscope, Accessories, Narrow Band Spectrum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Alternative Mode Of Visualization Using Narrow Bands From The Visible Spectrum For Illumination And Indicated For Endoscopy And Endoscopic Surgery Of The Upper And Lower Diagestive Tract And Urinary Tract.
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 - NWB Endoscope, Accessories, Narrow Band Spectrum

All 8
Devices cleared under the same product code (NWB) and FDA review panel - the closest regulatory comparables to K133538.
HD-550 Video Endoscope System
K222020 · Sonoscape Medical Corp. · Sep 2022
HD-550 Video Endoscope System
K211882 · Sonoscape Medical Corp. · Apr 2022
HD-500 Video Endoscope System
K173921 · Sonoscape Medical Corp. · Sep 2018
EVIS EXERAII 180 SYSTEM
K100584 · Olympus Medical Systems Corporation · Jul 2010
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
K090980 · Olympus Winter & Ibe GmbH · Jun 2009
EVIS EXERA II 180 SYSTEM
K072957 · Olympus Medical Systems Corporation · Mar 2008