Cleared Traditional

K233275 - RenaFlex Single-use Flexible Ureterosco...

Also marketed or referenced as:
RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse) Video System Center for Single-use Endoscopes (CV-S1)

K233275 is the FDA 510(k) clearance for RenaFlex Single-use Flexible Ureterosco... by Gyrus Acmi, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K233275 · Gyrus Acmi, Inc. · Gastroenterology & Urology device
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Mar 2024
Decision
178d
Days
Class 2
Risk

K233275 is an FDA 510(k) clearance for the RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard). Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Brooklyn Park, US). The FDA issued a Cleared decision on March 25, 2024 after a review of 178 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 Gyrus Acmi, Inc. devices

Submission Details

510(k) Number K233275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date March 25, 2024
Days to Decision 178 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
48d slower than avg
Panel avg: 130d · This submission: 178d
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 84
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K233275.
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
Video Ureteroscope System
K231135 · Hunan Vathin Medical Instrument Co., Ltd. · Jan 2024
CoralView® Single-use Digital Flexible Ureteroscope (U10)
K231774 · MacroLux Medical Technology Co., Ltd. · Jan 2024
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
K233645 · Boston Scientific Corporation · Dec 2023