Suprapubic Catheter and Introducer Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132890 FDA 510(k)
- FDA Product Code
- KOB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5090 FDA 510(k)
- Regulation Number
- 876.5090 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Suprapubic Catheter (And Accessories), classified as a Class II medical device under FDA regulations. It is designed for urinary drainage via a surgically created opening in the abdominal wall below the pubic bone, providing an alternative to urethral catheterisation for patients requiring long-term bladder drainage. The set includes a catheter and an introducer, facilitating safe and precise placement using the Seldinger technique. It is intended for use in clinical settings where urinary retention or obstruction necessitates external drainage.
The Suprapubic Catheter and Introducer Set is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K132890) and falls under the product code KOB, adhering to the regulatory requirements for Class II devices. The set is designed for use in urological and gastroenterological procedures, with sizes and configurations tailored for adult patients. Storage should follow manufacturer guidelines to maintain sterility, and proper disposal procedures must be observed post-use to ensure patient safety and infection control.
Frequently asked questions
What is the primary purpose of the Suprapubic Catheter and Introducer Set, and how does it differ from a urethral catheter?
The Suprapubic Catheter and Introducer Set is designed for urinary drainage through a surgically created opening in the abdominal wall below the pubic bone, serving as an alternative to urethral catheterization. It is specifically intended for patients requiring long-term bladder drainage, particularly when urethral catheterization is not feasible or desirable. Unlike urethral catheters, which pass through the urethra, this device avoids the urethra entirely, reducing risks like trauma or infection associated with urethral insertion.
Is this device intended for single-use or can it be reused? How should it be stored to maintain sterility?
The Suprapubic Catheter and Introducer Set is explicitly intended for single-use only, as indicated in the manufacturer’s instructions. To maintain sterility, storage must follow the manufacturer’s guidelines, which likely include keeping the package sealed and protected from contamination until use. Proper disposal procedures should also be observed post-use to ensure patient safety and infection control.
What sizes and configurations are available for this device, and is it suitable for adult patients only?
The set is designed specifically for adult patients, with sizes and configurations tailored to meet their needs. While exact measurements or model variations are not detailed in the provided data, the product code (KOB) and regulatory classification suggest it is engineered for standard adult anatomical requirements. For precise sizing options, refer to the manufacturer’s product catalog or technical specifications.
How is the Suprapubic Catheter and Introducer Set placed, and what technique does it use?
This device utilizes the Seldinger technique for placement, which involves guiding a guidewire through the introducer into the bladder before catheter insertion. This method ensures precise and safe catheter placement via the suprapubic route, reducing the risk of complications compared to traditional methods. The introducer facilitates this process by providing a controlled pathway for the catheter.
What regulatory pathway was followed for this device, and which advisory committees were involved?
The Suprapubic Catheter and Introducer Set was cleared through the FDA’s 510(k) pathway under the product code KOB, classified as a Class II device. The submission was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its dual relevance to both specialties. The clearance type is traditional, and the decision was based on a determination of substantial equivalence to a predicate device.
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: Suprapubic cystostomy - Wikipedia, S-Cath System - Mediplus Innovative Medical Devices, Suprapubischer Katheter: Indikation, Legen und Wechseln, S-Cath™ System - Mediplus Innovative Medical Devices, Suprapubic Catheter: Changing, Flushing & Recovery
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132890 | Class II | Active |
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Manufacturer
- Manufacturer
- Mediplus , Ltd.
Sources (1)
- FDA 510(k) K132890 24 fields · synced Sep 20, 2026