URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING

• K Number: K981344
• Device Name: URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
• Manufacturer: URESIL CORP.
• Date Cleared: 1998-09-10 ( 154 days)
• Product Code: LJE , FGE , GBO , GBX
• Regulation Number: N/A
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

For percutaneous drainage of abscess, nephrostomy and other fluids.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K981344 approval letter and "ATTACHMENT D" does not contain information about the acceptance criteria or a study proving that the device meets such criteria.

The documents primarily focus on the regulatory approval process for the Uresil Percutaneous Drainage Catheters with Hydrophilic Coating, stating that the device is substantially equivalent to legally marketed predicate devices. They outline the general controls provisions of the Federal Food, Drug, and Cosmetic Act, regulatory responsibilities, and the indications for use.

There is no mention of specific performance metrics, clinical or non-clinical study design, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Regulation Number and Section

N/A