Cleared Traditional

Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) (K243155) - FDA 510(k) Clearance

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

K243155 · Dongguan Zsr Biomedical Technology Company Limited · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2025
Decision
134d
Days
Class 2
Risk

K243155 is an FDA 510(k) clearance for the Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-.... Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Dongguan Zsr Biomedical Technology Company Limited (Dongguan, CN). The FDA issued a Cleared decision on February 11, 2025 after a review of 134 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 Dongguan Zsr Biomedical Technology Company Limited devices

Submission Details

510(k) Number K243155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date February 11, 2025
Days to Decision 134 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
4d slower than avg
Panel avg: 130d · This submission: 134d
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 Consultant

Landlink Healthcare Technology (Shanghai) Co., Ltd.
Kang Kyra

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K243155.
LumiRex Ureteroscope
K243532 · Contra Healthcare Solutions, LLC · Apr 2025
Flexible Ureterorenoscope (US27F-12-EU
K243857 · Shanghai AnQing Medical Instrument Co., Ltd. · Apr 2025
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P
K243708 · Scivita Medical Technology Co., Ltd. · Mar 2025
Digital Video Processor
K243117 · Hunan Vathin Medical Instrument Co., Ltd. · Jan 2025
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
K241956 · Hunan Endoso Life Technology Co., Ltd. · Jan 2025
Single use flexible ureteroscope (UR-D1)
K240074 · Shenzhen Besdata Technology Co., Ltd. · Oct 2024