Cleared Traditional

CoralView® Single-use Digital Flexible Ureteroscope (U10) (K231774) - FDA 510(k) Clearance

Also marketed or referenced as:
CoralView® Single-use Digital Flexible Ureteroscope (U10-B) CoralView® Single-use Digital Flexible Ureteroscope (U10-BR) CoralView® Single-use Digital Flexible Ureteroscope (U20) CoralView® Single-use Digital Flexible Ureteroscope (U20-B) CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231774 · MacroLux Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
209d
Days
Class 2
Risk

K231774 is an FDA 510(k) clearance for the CoralView® Single-use Digital Flexible Ureteroscope (U10). Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by MacroLux Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 11, 2024 after a review of 209 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 MacroLux Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K231774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date January 11, 2024
Days to Decision 209 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
79d slower than avg
Panel avg: 130d · This submission: 209d
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 76
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K231774.
Ureterorenoscope System
K240374 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · May 2024
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard)
K233275 · Gyrus Acmi, Inc. · Mar 2024
Video Ureteroscope System
K231135 · Hunan Vathin Medical Instrument Co., Ltd. · Jan 2024
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
K233645 · Boston Scientific Corporation · Dec 2023
Medical Video Endoscope System
K230475 · Huger Medical Instrument Co., Ltd. · Nov 2023
RenaNav Ureteroscope System
K223097 · CenterPoint Systems, LLC · Jul 2023