Visualized Access and Delivery Catheter - PB Digital Controller
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Visualized Access and Delivery Catheter EUDAMED
- Model / Reference
- SVS11009 EUDAMEDSVS22001 EUDAMEDSVS22008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902284546349 EUDAMED06902284545984 EUDAMED06902284546332 EUDAMED
- Basic UDI-DI
- 6902284CD6215994 EUDAMED
- 510(k) Number
- K252492 FDA 510(k)
- FDA Product Code
- SHU FDA 510(k)
- EMDN Code
- Z12020601 COLONOSCOPES EUDAMED
- Models / Variants
- PB Digital Controller FDA 510(k)EUDAMED
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
- Germany 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
The Visualized Access and Delivery Catheter; PB Digital Controller is a flexible appendiceal scope accessory designed for endoscopic procedures. It combines imaging capabilities with catheter-based delivery, enabling precise visualization and targeted intervention in gastrointestinal and urological applications.
This device is supplied as a reusable system, featuring MRI-safe components where applicable, and is intended for use in clinical settings such as gastroenterology and urology. It adheres to FDA 510(k) clearance (K252492) and MDR compliance, with a classification under regulation 876.1500. Sterility and single-use components, if present, are specified in the manufacturer’s instructions for use.
Frequently asked questions
What clinical specialties is this device primarily intended for, and how does its design support those specialties?
This device is designed for use in gastroenterology and urology procedures. Its flexible appendiceal scope accessory combines real-time imaging with catheter-based delivery, enabling precise visualization and targeted interventions in the gastrointestinal and urological tracts. The integrated imaging and delivery system helps clinicians navigate complex anatomical areas while performing interventions, improving accuracy and reducing procedural risks.
Is this system reusable, and if so, what considerations should clinicians take for maintenance and sterilization?
Yes, the Visualized Access and Delivery Catheter; PB Digital Controller is supplied as a reusable system. While the core components are designed for reuse, the manufacturer’s instructions for use specify any sterile single-use components that may be part of the procedure. Clinicians should follow the manufacturer’s guidelines for cleaning, disinfection, and maintenance to ensure safety and functionality, particularly since MRI-safe components are included where applicable.
What sizes or models are available for this device, and how might that affect procedure selection?
The specifications provided do not list explicit sizes or model variants, but the device is described as a flexible appendiceal scope accessory with catheter-based delivery. Clinicians should refer to the manufacturer’s documentation for detailed sizing options, as these may influence compatibility with different endoscopic instruments and patient anatomies. The flexibility of the design suggests adaptability for various procedural needs in gastroenterology and urology.
How does the PB Digital Controller enhance the functionality of the catheter system, and what types of procedures might benefit most?
The PB Digital Controller integrates with the catheter system to provide imaging capabilities, allowing real-time visualization during endoscopic procedures. This is particularly useful in gastroenterology and urology for interventions requiring precision, such as biopsies, drainage, or targeted drug delivery. The controller’s digital interface likely improves accuracy, reduces fluoroscopy reliance, and enhances procedural control in complex cases.
What regulatory pathways does this device follow, and how does that affect its use in clinical settings?
The device is cleared under FDA 510(k) (K252492) and complies with MDR (Medical Device Regulation) standards, with a classification under regulation 876.1500. This means it has undergone regulatory review for safety and effectiveness in its intended clinical applications—gastroenterology and urology—and is authorized for use in settings adhering to these regulatory frameworks. Clinicians should confirm compliance with local health authority requirements before use.
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. Sources consulted: Visualized Access and Delivery Catheter; PB Digital Controller (K252492 ..., Visualized Access and Delivery Catheter; PB Digital Controller, Visualized Access and Delivery Catheter; PB Digital Controller 510(k ..., PDF Sally He Regional RA Manager Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke ...
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 | K252492 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (4)
- FDA 510(k) K252492 24 fields · synced Sep 18, 2026
- EUDAMED 30188863-5cf4-4dc9-89a8-bb3b059f28fa 61 fields · synced Jul 10, 2026
- EUDAMED c61f0178-a218-45df-b9b8-c9c02833d1f7 61 fields · synced Jul 12, 2026
- EUDAMED 372e9952-2742-4b03-895e-90990054f71d 61 fields · synced Jul 13, 2026