Ureteral Catheter
by Cook Urological, Inc. 510(k)
Active
510(k) K923729
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923729 | Date7 Dec 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EYB
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Ureteral Catheter is a medical device classified under the nomenclature for Catheter, Ureteral, Gastro-Urology, designed for insertion into the ureter to facilitate access, drainage, or irrigation of the urinary tract. It enables the delivery of contrast media, fluid drainage, and irrigation while navigating tortuous ureters or assisting in wire guide placement for procedural access.
This device is supplied as a single-use, sterile medical instrument and is regulated under FDA 510(k) clearance (K923729) as substantially equivalent to predicate devices. It is intended for use in clinical settings such as urology and gastroenterology, with no specific MRI safety restrictions noted. Sizes and lumen configurations (e.g., open-end or dual lumen) may vary by model, and storage follows standard sterile medical device protocols.
Other devices from Cook Urological, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical specialties commonly use the Ureteral Catheter from Cook Urological, Inc.?
The Ureteral Catheter is primarily used in urology and gastroenterology procedures. Its design supports access, drainage, irrigation, and contrast media delivery within the urinary tract, making it suitable for navigating complex anatomical structures like tortuous ureters or assisting with wire guide placement during interventions.
Is the Ureteral Catheter reusable or intended for single-use only?
The Ureteral Catheter is explicitly supplied as a single-use, sterile medical device. This aligns with standard sterile instrument protocols to ensure patient safety and prevent cross-contamination between uses.
What types of lumen configurations are available for this catheter, and how might they differ in function?
The Ureteral Catheter may include variations like open-end or dual-lumen designs, depending on the model. Open-end catheters facilitate straightforward drainage or irrigation, while dual-lumen models allow simultaneous access for contrast media delivery *and* fluid drainage, enhancing procedural flexibility in complex cases.
How should the Ureteral Catheter be stored to maintain sterility and functionality?
Storage follows standard sterile medical device protocols, which typically involve keeping the catheter in its original, sealed packaging until immediate use. Avoid exposure to moisture, extreme temperatures, or physical damage to preserve sterility and structural integrity.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and equivalence?
The Ureteral Catheter received FDA 510(k) clearance (K923729) under the *Traditional* review pathway, determined to be *substantially equivalent* to predicate devices. This means the FDA evaluated it against legally marketed competitors and concluded it has the same intended use, technological characteristics, and performance as those predecessors, ensuring it meets applicable safety and effectiveness standards.