← Back to catalogue

Luja female (20051) +3 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241028

by Coloplast

Identifiers

510(k) Number
K241028 FDA 510(k)
FDA Product Code
EZD FDA 510(k)
Models / Variants
Luja female (20051) FDA 510(k)
Luja female (20052) FDA 510(k)
Luja female (20054) FDA 510(k)
Luja female (20056) 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 Luja Female catheters are straight, single-use, intermittent urinary catheters designed for female patients. These devices are intended for temporary bladder drainage, facilitating complete bladder emptying with a compact, easy-to-use form. The catheters feature a Micro-hole Zone Technology, which helps reduce the risk of urinary tract infections by ensuring efficient drainage in a single free-flow procedure.

Supplied sterile and packaged individually, these catheters are available in four sizes: 10-ch, 12-ch, 14-ch, and 16-ch, each with a 9 cm length. They are classified as Class II devices under FDA regulations and have received 510(k) clearance for use in gastroenterology and urology settings. The catheters are intended for single-use only and must be disposed of after one use. No MRI safety information is specified, and proper storage conditions include protection from moisture and contamination.

Frequently asked questions

What is the Luja Female Catheter designed for?

The Luja Female Catheter is a straight, single-use intermittent urinary catheter specifically designed for female patients. It facilitates temporary bladder drainage by ensuring complete emptying during a single procedure. The Micro-hole Zone Technology helps minimize urinary tract infections by promoting efficient drainage, making it ideal for clinical settings where quick and reliable bladder emptying is required.

How are the Luja Female Catheters supplied and what are their sizes?

The Luja Female Catheters are supplied sterile and individually packaged to maintain sterility. They come in four sizes: 10-ch, 12-ch, 14-ch, and 16-ch, each with a consistent length of 9 cm. This variety allows clinicians to select the appropriate size based on patient needs, ensuring a comfortable and effective fit.

Are the Luja Female Catheters reusable or single-use?

The Luja Female Catheters are intended for single-use only. After one use, they must be disposed of properly to prevent contamination and ensure patient safety. This design aligns with best practices for reducing infection risks in medical procedures.

What storage conditions should be followed for these catheters?

To maintain sterility and functionality, the Luja Female Catheters must be stored in a clean, dry environment protected from moisture and contamination. The individual sterile packaging should remain intact until use. Proper storage ensures the device remains effective and safe for clinical application.

Can the Luja Female Catheters be used in MRI procedures?

The device data does not specify MRI safety information for the Luja Female Catheters. Clinicians should verify compatibility with MRI equipment and protocols before use in magnetic resonance imaging settings to avoid potential risks.

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: Luja™ female - products.coloplast.co.uk, Luja™ Female - Coloplast, Luja™ female - products.coloplast.us, Luja™ für Männer und Jungen - Coloplast

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Coloplast

Sources (1)

  • FDA 510(k) K241028 24 fields · synced Oct 5, 2026