Cleared Traditional

K142556 - Flexible Video-Uretero-Choledochoscope ...

K142556 is the FDA 510(k) clearance for Flexible Video-Uretero-Choledochoscope ... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K142556 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
42d
Days
Class 2
Risk

K142556 is an FDA 510(k) clearance for the Flexible Video-Uretero-Choledochoscope System. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on October 23, 2014 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K142556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2014
Decision Date October 23, 2014
Days to Decision 42 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
88d faster than avg
Panel avg: 130d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FGB Ureteroscope And Accessories, Flexible/rigid

All 85
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K142556.
OLYMPUS URF-V2/V2R
K172246 · Olympus Medical Systems Corp. · Mar 2018
OLYMPUS URF-P6/P6R
K172298 · Olympus Medical Systems Corp. · Mar 2018
LithoVue System
K153049 · Boston Scientific Corporation · Nov 2015
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K141250 · KARL STORZ Endoscopy-America, Inc. · Jun 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K131369 · KARL STORZ Endoscopy-America, Inc. · Nov 2013
STRYKER VIDEO URETEROSCOPE
K121112 · Stryker Endoscopy · Sep 2012