Cleared Special

K262552 - Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)

K262552 is an FDA 510(k) clearance for Single-use Flexible Ureteroscope (Singl..., manufactured by Scivita Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Special 510(k) pathway after a 21-day FDA review.

K262552 · Scivita Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
21d
Days
Class 2
Risk

K262552 is an FDA 510(k) clearance for the Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B). Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Scivita Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 14, 2026 after a review of 21 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 Scivita Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K262552

510(k) Number K262552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2026
Decision Date August 14, 2026
Days to Decision 21 days
Submission Type Special
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
110d faster than avg
Panel avg: 131d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

FGB Device Classification - Class 2, Special Controls

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 100
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K262552.
LithoVue Elite Digital Flexible Ureteroscope System
K261153 · Boston Scientific Corporation · Aug 2026
Zamenix™ P
K253505 · Roen Surgical, Inc. · Aug 2026
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
K260516 · MacroLux Medical Technology Co., Ltd. · Jul 2026
Single Use Digital Flexible Ureteroscope (7.5F)
K252929 · Anhui Happiness Workshop Instruments Co., Ltd. · Apr 2026
CVAC Image Processor
K260013 · Calyxo, Inc. · Mar 2026
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3)
K251951 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Dec 2025