Cleared Traditional

Single-Use Video Flexible Ureterorenoscope System (K221158) - FDA 510(k) Clearance

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

K221158 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Gastroenterology & Urology device
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Mar 2023
Decision
319d
Days
Class 2
Risk

K221158 is an FDA 510(k) clearance for the Single-Use Video Flexible Ureterorenoscope System. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Guangzhou Red Pine Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 6, 2023 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Guangzhou Red Pine Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K221158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2022
Decision Date March 06, 2023
Days to Decision 319 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 130d · This submission: 319d
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 K221158.
RenaNav Ureteroscope System
K223097 · CenterPoint Systems, LLC · Jul 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
K231878 · STERIS Corporation · Jul 2023
Single-Use Flexible Ureteroscope
K230200 · Hunan Vathin Medical Instrument Co., Ltd. · May 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101
K223466 · STERIS Corporation · Feb 2023
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
K221515 · Boston Scientific Corporation · Feb 2023
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K222737 · Shanghai AnQing Medical Instrument Co., Ltd. · Oct 2022