Cleared Special

Single-use Video Ureterorenoscope (SVU-220US) (K241639) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241639 · Huger Medical Instrument Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2024
Decision
24d
Days
Class 2
Risk

K241639 is an FDA 510(k) clearance for the Single-use Video Ureterorenoscope (SVU-220US). Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Huger Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 1, 2024 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Huger Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K241639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2024
Decision Date July 01, 2024
Days to Decision 24 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 130d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K241639.
KARL STORZ Fiber Telescopes for Urology
K233372 · Karl Storz SE & CO. KG · Jul 2024
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
K233778 · Zhuhai Pusen Medical Technology Co., Ltd. · Jul 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000)
K241598 · Boston Scientific Corporation · Jul 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
K233630 · Ambu A/S · Jun 2024
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
K232911 · Karl Storz Endovision, Inc. · Jun 2024
Ureterorenoscope System
K240374 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · May 2024