Ready to use Nelaton Catheter

The Ready to use Nelaton Catheter is a sterile, single-use, prelubricated urological catheter made of polyurethane for intermittent catheterization. It is indicated for individuals (men, women, and pediatrics) unable to promote natural urine flow or who have significant residual urine after bladder voiding. The catheter is inserted through the urethra to the bladder to allow urine drainage and ensure complete bladder emptying.

The device features a polyurethane shaft with a hydrophilic coating (polyacrylamide derivatives), two polished eyelets for drainage, and a color-coded funnel for collection container connection. Available in multiple French sizes and lengths for adults and pediatrics, with straight Nelaton or curved Tiemann tip options. A gripper on adult male catheters provides no-touch insertion. Sealed in a peel pack with distilled water hydration liquid, sterilized by E-beam irradiation with a 3-year shelf life. Key difference from predicate: uses polyacrylamide derivative coating instead of PVP, and includes a gripper instead of sleeve.

ISO 20696:2018 (catheter performance), ISO 10993-1, 10993-5, 10993-23, 10993-10, and 10993-11 (biocompatibility), ISO 11137-1, 11137-2, and 11137-3 (sterilization validation), ASTM F1980-21 (shelf-life aging), ASTM F2096-11 (package integrity), ASTM D4169-23 (transportation testing), and USP <151> (pyrogenicity).

The proposed device is substantially equivalent to predicate K192468 because both share identical regulatory classification (Class II), indications for use (intermittent catheterization for adults and pediatrics), intended patients, single-use and ready-to-use design, and similar technical characteristics including polyurethane shaft, prelubrication by water hydration, and comparable tip designs. Non-clinical testing demonstrated no significant statistical differences in coating performance and equivalent performance to the predicate. Minor design differences (polyacrylamide vs. PVP coating, gripper vs. sleeve) do not raise different safety or effectiveness questions.