Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Single-use Flexible Ureteroscope EUDAMED
- Device Name
- Single-use Flexible Ureteroscope EUDAMED
- Model / Reference
- SUV-1A-B,SUV-1A-P,SUV-2A-B,SUV-2A-P,SUV-2B-B,SUV-2B-P,SUV-2C-B,SUV-2C-P,SUV-3A-B,SUV-3C-B,SUV-4A-B,SUV-4C-B EUDAMEDSUV-2A-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381254204 EUDAMED
- Basic UDI-DI
- 697138125007A8H EUDAMED
- Direct Marketing DI
- 06971381254204 EUDAMED
- 510(k) Number
- K243708 FDA 510(k)
- FDA Product Code
- FGB FDA 510(k)
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
This system comprises single-use flexible ureteroscopes and cystoscopes, designed for endoscopic visualization of the urinary tract. The flexible ureteroscopes (SUV-1A, SUV-2A, SUV-2B, SUV-2C) and cystoscopes (SUV-1D) enable minimally invasive examination of the bladder, ureters, and renal pelvis, while the endoscopic image processor (HDVS-S100A, HDVS-S100D) provides high-definition imaging for diagnostic and procedural guidance.
The system is intended for single-use in clinical settings, ensuring sterility and reducing infection risk. Each component is classified as Class II under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The devices are non-MRI compatible and must be stored in accordance with manufacturer instructions to maintain integrity until use.
Frequently asked questions
What types of scopes are included in this urology videoscope system, and how are they differentiated?
The system includes single-use flexible ureteroscopes (models SUV-1A, SUV-2A, SUV-2B, SUV-2C) and single-use flexible cystoscopes (model SUV-1D). The differentiation lies in their intended anatomical focus: ureteroscopes are designed for visualization of the ureters and renal pelvis, while the cystoscope is specifically for the bladder. The ‘B’ and ‘P’ suffixes (e.g., SUV-1A-B, SUV-1A-P) likely denote variations in insertion length or tip design, but the exact clinical distinction requires consulting the manufacturer’s instructions.
Are the scopes reusable, or are they intended for single-use only? How does this impact infection control?
The scopes are explicitly designed for single-use only, eliminating the need for reprocessing and significantly reducing infection risks. This aligns with modern clinical best practices for urinary tract endoscopy, as single-use devices minimize cross-contamination between patients and simplify sterilization workflows.
What should I consider when storing these devices before use, and how long can they remain unopened?
The manufacturer’s storage instructions must be followed to maintain device integrity, though the exact shelf life isn’t specified. Generally, single-use endoscopes like these are packaged in sterile barriers and should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Check the packaging for expiration dates or storage conditions, as improper handling could compromise sterility or functionality.
Is the image processor part of the system compatible with MRI environments, and what imaging quality can I expect?
The endoscopic image processors (HDVS-S100A, HDVS-S100D) are not MRI-compatible, meaning they cannot be used in or near MRI machines. The system provides high-definition imaging, which is critical for diagnostic clarity during urological procedures like stone removal or lesion evaluation, but the exact resolution or frame rate would require reviewing the manufacturer’s technical specifications.
How do I know which scope model is appropriate for my patient’s procedure, and are there size variations?
The scope models (e.g., SUV-1A vs. SUV-2C) likely differ in insertion length, working channel diameter, or tip flexibility to suit specific anatomical needs—such as pediatric vs. adult patients or complex ureteral access. For example, shorter models (e.g., SUV-1A) may be better for pediatric cases, while longer or more flexible scopes (e.g., SUV-2C) could be preferred for adult renal procedures. Consult the manufacturer’s procedural guidelines or your institution’s urology team to select the appropriate model based on patient anatomy and clinical indication.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243708 | Class II | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K243708 24 fields · synced Sep 18, 2026
- EUDAMED 829f65e0-3451-4248-a42e-f7b09ed30f1d 61 fields · synced Jul 22, 2026