Cleared Traditional

K261153 - LithoVue Elite Digital Flexible Ureteroscope System

K261153 is an FDA 510(k) clearance for LithoVue Elite Digital Flexible Uretero..., manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K261153 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
140d
Days
Class 2
Risk

K261153 is an FDA 510(k) clearance for the LithoVue Elite Digital Flexible Ureteroscope System. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on August 26, 2026 after a review of 140 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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K261153

510(k) Number K261153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2026
Decision Date August 26, 2026
Days to Decision 140 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 Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 131d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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 100
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K261153.
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
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
K260516 · MacroLux Medical Technology Co., Ltd. · Jul 2026
Single Use Digital Flexible Ureteroscope (7.5F)
K252929 · Anhui Happiness Workshop Instruments Co., Ltd. · Apr 2026
CVAC Image Processor
K260013 · Calyxo, Inc. · Mar 2026
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3)
K251951 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Dec 2025