Ureteroscopy Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K850335 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Celestin Pulsion Esophogeal Prosthesis

  Class II

  FDA 510(k) K813169 Active Cleared 3 Dec 1981

• Deaver T-Drain & Cattel T-Drain

  Class II

  FDA 510(k) K841034 Active Cleared 13 Apr 1984

• Blakemore Tube

  Class II

  FDA 510(k) K841038 Active Cleared 13 Apr 1984

• Rectal Balloon Catheters

  Class II

  FDA 510(k) K841036 Active Cleared 13 Apr 1984

• Cole Tube-Latex

  Class II

  FDA 510(k) K840973 Active Cleared 30 Mar 1984

• Nasopharyngeal Airways

  Class I

  FDA 510(k) K841093 Active Cleared 23 Mar 1984

See all devices from Inmed Corp. →

• What is the Inmed Ureteroscopy Catheter used for?

  The Inmed Ureteroscopy Catheter is designed for insertion into the ureter to assist with ureteroscopic procedures. It facilitates visualization, irrigation, or drainage of the ureter, helping to manage conditions such as stones, strictures, or tumors while minimizing trauma to surrounding tissues. This makes it particularly useful in operating rooms or endoscopy suites for minimally invasive urological interventions.

• Is the Inmed Ureteroscopy Catheter single-use or reusable?

  The Inmed Ureteroscopy Catheter is supplied as a single-use device. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in clinical settings where infection control is paramount.

• What sizes or configurations are available for the Inmed Ureteroscopy Catheter?

  The catheter is available in various sizes and configurations to accommodate different patient anatomies and procedural requirements. While the exact specifications are not detailed here, the range of sizes ensures flexibility for clinicians to select the most appropriate option for their patients, whether for pediatric, adult, or specialized cases.

• How should the Inmed Ureteroscopy Catheter be stored?

  Since the catheter is single-use and sterile, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the device remains uncontaminated and maintains its integrity until use.

• Is the Inmed Ureteroscopy Catheter safe for use with MRI?

  The available data does not indicate specific MRI safety labeling for the Inmed Ureteroscopy Catheter. Clinicians should verify compatibility with their MRI equipment and protocols before use, particularly if the catheter contains metallic components or materials that could interfere with imaging.