Acucise Ureteral Cutting Catheter

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

510(k) Number

K921838 ↗

FDA Product Code

EYB

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Sureseal Endoscopic Valve

  Class II

  FDA 510(k) K920030 Active Cleared 18 Mar 1992

• Ureteral Stent

  Class II

  FDA 510(k) K920695 Active Cleared 23 Sep 1992

• Disposable Aspiration Irrigation System

  Class II

  FDA 510(k) K912093 Active Cleared 24 Apr 1992

• Urethral Electrode Sheath

  Class II

  FDA 510(k) K915219 Active Cleared 23 Jul 1992

• Endoscopic Electrode

  Class II

  FDA 510(k) K912656 Active Cleared 16 Sep 1991

• Rigid Ureteroscope

  Class II

  FDA 510(k) K901214 Active Cleared 1 Jun 1990

See all devices from Applied Urology, Inc. →

• What is the Acucise Ureteral Cutting Catheter used for?

  The Acucise Ureteral Cutting Catheter is designed specifically for endoureterotomy procedures. It features a cutting mechanism to incise ureteral strictures, helping to restore proper urinary flow in cases where the ureter is obstructed. This device is intended for use in controlled clinical settings where precise ureteral intervention is required, such as in outpatient or hospital-based urological procedures.

• Is the Acucise Ureteral Cutting Catheter single-use or reusable?

  The Acucise Ureteral Cutting Catheter is supplied as a single-use device. This design ensures sterility and safety for one-time clinical use, reducing the risk of contamination or cross-infection between patients. Always follow the manufacturer’s guidelines to maintain proper handling and sterility.

• What are the key specifications or features of this catheter?

  The catheter is classified under gastro-urology applications and is intended for endoureterotomy procedures. It is FDA 510(k) cleared (K921838) and falls under device class II. The device is not MRI-compatible, meaning it should not be used in MRI environments. While specific sizes or storage conditions are not detailed in the regulatory data, it is designed for precise ureteral intervention in controlled clinical settings.

• How should the Acucise Ureteral Cutting Catheter be stored?

  The manufacturer specifies that the Acucise Ureteral Cutting Catheter is intended for single-use and sterile use. While the exact storage conditions are not detailed in the provided data, it is critical to store the device in a clean, dry environment, protected from contamination, and follow standard sterile packaging guidelines to preserve its integrity until use.

• What regulatory pathway does this device follow?

  The Acucise Ureteral Cutting Catheter has undergone FDA 510(k) clearance (K921838), which means it has been determined to be substantially equivalent to a legally marketed device that was not required to undergo premarket approval. This classification places it under device class II, indicating a moderate level of regulatory oversight. The device is also associated with the gastroenterology and urology advisory committees.