Cleared Traditional

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box (K223926) - FDA 510(k) Clearance

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

K223926 · Medimaging Integrated Solution, Inc (Miis) · Gastroenterology & Urology device
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Oct 2023
Decision
280d
Days
Class 2
Risk

K223926 is an FDA 510(k) clearance for the VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Medimaging Integrated Solution, Inc (Miis) (Hsinchu, CN). The FDA issued a Cleared decision on October 6, 2023 after a review of 280 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 Medimaging Integrated Solution, Inc (Miis) devices

Submission Details

510(k) Number K223926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2022
Decision Date October 06, 2023
Days to Decision 280 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
150d slower than avg
Panel avg: 130d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform 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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 49
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K223926.
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)
K240283 · MacroLux Medical Technology Co., Ltd. · Jun 2024
Uro-G HD Flexible Cystoscope
K232837 · Uroviu Corporation · Jun 2024
Cystoscope System
K231118 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Nov 2023
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet
K231702 · OTU Medical, Inc. · Sep 2023
Endo SmartCap
K223040 · Medivators, Inc. · Mar 2023
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
K221683 · Olympus Medical Systems Corporation · Jan 2023