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Closed System Urethral Catheteriz. Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K803259

by Medical Devices Inc.

Identifiers

510(k) Number
K803259 FDA 510(k)
FDA Product Code
KOD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Closed System Urethral Catheterization Set, classified as a Class II urological catheter under FDA regulations. It is designed for the sterile insertion of a urethral catheter to facilitate urinary drainage while minimizing contamination risk by maintaining a sealed system between the catheter and collection bag.

The set is intended for single-use in clinical or home-care settings and includes pre-lubricated components to ensure ease of insertion. Supplied sterile and packaged for aseptic use, it adheres to FDA 510(k) clearance (K803259) under the Gastroenterology and Urology advisory committee. No reusable or MRI-compatible variants are specified; sizes or additional accessories are not detailed in the regulatory submission.

Frequently asked questions

What clinical settings is this closed system urethral catheterization set designed for, and how does it differ from traditional catheterization methods?

This closed system urethral catheterization set is specifically designed for sterile insertion in both clinical (hospital) and home-care settings. The key difference from traditional open systems is its sealed design, which minimizes contamination risk by maintaining a barrier between the catheter and the urine collection bag. This helps reduce the likelihood of urinary tract infections, a common complication with open systems.

Is this device intended for single-use only, and if so, why is that important?

Yes, this device is explicitly intended for single-use only. This is important because single-use devices are pre-sterilized and packaged to ensure aseptic conditions during insertion, reducing the risk of cross-contamination between patients. Reusing medical devices can introduce pathogens and compromise patient safety, which is why this set is not designed for reuse.

Are there any pre-insertion preparations required, such as lubrication, and how does that affect ease of use?

No pre-insertion lubrication is required by the user, as the set includes pre-lubricated components. This design feature simplifies the procedure by eliminating the need for additional preparation steps, making it easier for clinicians or caregivers to perform catheterization quickly and with less risk of irritation or discomfort for the patient.

How should this device be stored, and what precautions should be taken to maintain its sterility?

The device is supplied sterile and packaged for aseptic use, so it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until use to preserve sterility. Avoid storing it in areas prone to moisture or contamination, such as near restrooms or cleaning supplies.

What regulatory pathway was followed for this device, and how does that affect its availability or use?

This device followed the FDA’s 510(k) clearance pathway, specifically under the Gastroenterology and Urology advisory committee, with a clearance number of K803259. This means it was deemed *substantially equivalent* to a predicate device already on the market, ensuring it meets FDA safety and effectiveness standards. While this does not imply current availability or approval status, it confirms the device was reviewed for compliance with FDA regulations for Class II urological catheters.

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: Closed System Urethral Catheteriz. Set 510 (k) FDA Premarket ..., Closed System Catheter - Self Catheterization Kits | Vitality Medical, Closed System Catheters and Catheter Kits at 180 Medical, Closed System Catheters for Sale - Intermittent Catheters & Kits

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Devices Inc.
FDA Applicant
Medical Devices, Inc.

Sources (1)

  • FDA 510(k) K803259 24 fields · synced Sep 18, 2026