Intermittent Nelaton Catheter for Single Use
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222677 FDA 510(k)
- FDA Product Code
- EZD 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)
The Intermittent Nelaton Catheter for Single Use is a straight catheter designed for temporary urinary drainage. It is a flexible, tubular device with a smooth, rounded tip intended to facilitate insertion into the urethra and bladder with minimal trauma, reducing the risk of irritation or obstruction. Nelaton catheters are commonly used in clinical settings for intermittent catheterization, particularly in patients who require periodic bladder emptying but do not need continuous drainage.
This device is supplied as a single-use, sterile product and is classified as a Class II medical device under FDA regulations (21 CFR § 876.5130). It is intended for use in urological and gastroenterological procedures, adhering to standard aseptic techniques. The catheter is non-reusable and must be discarded after one use to prevent cross-contamination. No specific MRI safety information is provided, but its use is restricted to non-magnetic environments unless otherwise specified by the manufacturer. Sizes and packaging details are not explicitly stated in the data but are typically determined by the manufacturer’s specifications for each lot.
Frequently asked questions
What is the primary purpose of the Intermittent Nelaton Catheter for Single Use and how does its design reduce patient discomfort during use?
The Intermittent Nelaton Catheter for Single Use is designed for temporary urinary drainage, specifically for patients who require periodic bladder emptying but do not need continuous drainage. Its smooth, rounded tip is engineered to minimize trauma during insertion into the urethra and bladder, reducing irritation or obstruction and thereby lowering patient discomfort.
Is this catheter reusable, and if not, what are the implications for infection control in clinical settings?
No, this catheter is explicitly labeled for single-use only and must be discarded after one use. This design prevents cross-contamination between patients, which is critical for infection control in clinical settings where aseptic techniques are mandatory.
What regulatory pathway was followed for this device’s approval, and which advisory committees were involved?
The Intermittent Nelaton Catheter for Single Use underwent a Traditional 510(k) review and was determined to be substantially equivalent to a predicate device. The Gastroenterology and Urology (GU) Advisory Committee was involved in the review process, as indicated by the advisory committee description.
Are there any specific storage or handling instructions mentioned for this catheter, particularly regarding sterility?
While the data does not specify exact storage instructions, the catheter is sterile for single-use and must be handled under aseptic techniques to maintain sterility. Standard medical device storage practices—such as keeping it in a sealed, dry environment away from direct sunlight—should be followed to preserve its integrity.
Can this catheter be used in patients who require MRI scans, or are there any restrictions?
The provided data does not explicitly state MRI compatibility, but it notes that the catheter’s use is restricted to non-magnetic environments unless otherwise specified by the manufacturer. Clinicians should verify compatibility with their MRI facility 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: Intermittent nelaton catheter for single use (K222677) — FDA 510 (k ..., K222677 FDA 510(k) - Intermittent nelaton catheter for singl..., Intermittent nelaton catheter for single use - FDA 510(k) K222677
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222677 | Class II | Active |
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Manufacturer
- Manufacturer
- Hangzhou Jimushi Meditech Co., Ltd.
Sources (1)
- FDA 510(k) K222677 24 fields · synced Sep 20, 2026