Cleared Traditional

K260708 - Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection)

Also marketed or referenced as:
Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection)

K260708 is an FDA 510(k) clearance for Vein360 Reprocessed LithoVue Digital Fl..., manufactured by Vein 360. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K260708 · Vein 360 · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
230d
Days
Class 2
Risk

K260708 is an FDA 510(k) clearance for the Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection). Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Vein 360 (Cincinnati, US). The FDA issued a Cleared decision on October 20, 2026 after a review of 230 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 - K260708

510(k) Number K260708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2026
Decision Date October 20, 2026
Days to Decision 230 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
99d slower than avg
Panel avg: 131d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGB Device Classification - Class 2, Special Controls

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 120
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K260708.
Single-use Digital Flexible Ureteroscope (GY-UR6.3)
K262437 · Zhejiang Geyi Medical Instrument Co., Ltd. · Oct 2026
CVAC® Aspiration System
K261447 · Calyxo, Inc. · Sep 2026
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
K262488 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Sep 2026
LithoVue Elite Digital Flexible Ureteroscope System
K261153 · Boston Scientific Corporation · Aug 2026
Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
K262552 · Scivita Medical Technology Co., Ltd. · Aug 2026
Zamenix™ P
K253505 · Roen Surgical, Inc. · Aug 2026
K260708 · Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection)
Download PDF FDA Summary Vein 360