Bard Aquaguide Ureteral Conduit Modification
510(k) K033778
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033778 | Date30 Dec 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Modification to Bard Aquaguide Ureteral Conduit
- 510(k) Number
- FDA Product Code
- FED
- FDA applicant
- C.R. Bard, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Bard Aquaguide Ureteral Conduit Modification is an Endoscopic Access Overtube designed for ureteral dilation and access. It functions as a two-component system, featuring a hydrophilic-coated introducer paired with a dual-lumen sheath equipped with a multi-function access hub. This device facilitates controlled dilation and sustained ureteral access during endoscopic urology procedures.
This modification is intended for single-use in sterile clinical settings, adhering to FDA 510(k) clearance (K033778) under Special Controls for Class II devices. Supplied as a sterile, disposable system, it is regulated under product code FED for Gastroenterology-Urology applications. No MRI safety or reusable specifications are noted in the data.
Other devices from C. R. Bard, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Bard Aquaguide Ureteral Conduit Modification in clinical procedures?
The Bard Aquaguide Ureteral Conduit Modification is designed as an Endoscopic Access Overtube specifically for ureteral dilation and access during endoscopic urology procedures. It combines a hydrophilic-coated introducer with a dual-lumen sheath and a multi-function access hub to enable controlled dilation and sustained ureteral access, simplifying complex interventions like ureteroscopy.
Is this device intended for single-use or repeated use in clinical settings?
The Bard Aquaguide Ureteral Conduit Modification is explicitly intended for single-use only in sterile clinical settings. This is reinforced by its classification as a sterile, disposable system under FDA 510(k) clearance, ensuring compliance with infection control protocols for endoscopic procedures.
How is the device packaged and prepared for use in a sterile environment?
The device is supplied as a sterile, disposable system, meaning it arrives pre-sterilized and ready for immediate use in clinical settings. No additional sterilization is required before use, as it adheres to standard sterile packaging protocols for single-use medical devices.
What regulatory pathway was followed for FDA clearance of this modification?
The Bard Aquaguide Ureteral Conduit Modification received FDA 510(k) clearance (K033778) under Special Controls for Class II devices, with a determination of Substantially Equivalent to a predicate device. The clearance falls under product code FED (Gastroenterology-Urology) and was reviewed by the Gastroenterology-Urology (GU) Advisory Committee.
Are there any specific storage requirements mentioned for this device?
While the provided data does not detail exact storage conditions (e.g., temperature or humidity), the device is sterile and single-use, so it must be stored according to standard protocols for sterile, disposable medical devices—typically in a clean, dry environment protected from contamination until use. Always follow manufacturer guidelines for optimal shelf life.