ADVANCED UROLOGICAL CATHETER

• K Number: K053429
• Device Name: ADVANCED UROLOGICAL CATHETER
• Manufacturer: ENTRACARE, LLC
• Date Cleared: 2006-02-08 ( 61 days)
• Product Code: EZL , FCM , FCN
• Regulation Number: 876.5130
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the "Advanced Urological Catheter" by EntraCare LLC. It details the regulatory approval process but does not contain information regarding
acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific study-related details requested.

Therefore, I cannot provide the requested information from the given text.

The document primarily focuses on:

• The product name and applicant.
• The regulatory classification and product codes.
• Confirmation of substantial equivalence to a legally marketed predicate device.
• General regulatory requirements the manufacturer must adhere to.
• The intended use of the device: "The Advanced Urological Catheter is used to pass fluids to or from the urinary tract."

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.