Ureteral Dilation Set

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

510(k) Number

K832808 ↗

FDA Product Code

EZN

Device Class

Class II

Regulation

21 CFR Part 876.5470

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K851162 Active Cleared 15 Apr 1985

• Van-Tec Pediatric Suprapubic Catheter Set

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  FDA 510(k) K870555 Active Cleared 10 Mar 1987

• Ureteral Catheter Connecting Tube

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  FDA 510(k) K820866 Active Cleared 26 Apr 1982

• Van-Tec Disposable Flexible Endoscope

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• Van-Tec Segura Stone Basket W/Protective Sheath

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  FDA 510(k) K870696 Active Cleared 30 Mar 1987

• Van-Tec Bladder Evacuator

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  FDA 510(k) K880099 Active Cleared 2 Mar 1988

See all devices from Van-Tec, Inc. →

• What clinical specialties commonly use the Ureteral Dilation Set, and why is it relevant to those fields?

  The Ureteral Dilation Set is primarily used in urology and gastroenterology procedures. It is designed to gradually expand the ureter, which helps relieve obstructions or strictures—common issues in urology—while also facilitating the passage of other instruments, such as stents or scopes, which may be used in gastroenterology for diagnostic or therapeutic interventions.

• Is this device intended for reuse, or is it meant to be used only once? How does that affect its handling?

  The Ureteral Dilation Set is single-use only, meaning it should not be reused after a single procedure. This design ensures patient safety by eliminating the risk of cross-contamination or degradation of materials between uses. Since it is supplied sterile, no additional sterilization is required, simplifying handling and reducing the risk of procedural errors.

• What does the FDA’s 510(k) clearance (K832808) mean for this device, and how does it relate to its use in clinical settings?

  The FDA’s 510(k) clearance (K832808) confirms that the Ureteral Dilation Set is substantially equivalent to predicate devices already on the market, meaning it meets the same safety and effectiveness standards. This clearance does not define clinical indications but assures clinicians that the device has undergone regulatory review for its intended use—gradual ureteral dilation—as described in the manufacturer’s labeling.

• How many sizes or models of dilators are included in this set, and what determines the selection of a specific size?

  The Ureteral Dilation Set includes multiple tapered dilators, as indicated by the extensive list of registration numbers (e.g., 3006546082, 3013557562, etc.), which correspond to different sizes or variations of the device. The selection of a specific size depends on the degree of ureteral obstruction or stricture being treated, as well as the clinical judgment of the practitioner to ensure safe and effective dilation without causing trauma.

• How should the Ureteral Dilation Set be stored, and what precautions should be taken to maintain its sterility?

  Since the set is supplied sterile, it should be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment, protected from extreme temperatures, moisture, or direct sunlight. Avoid exposing it to contaminants or rough handling, as this could compromise its sterility before use. Always check the expiration date and integrity of the packaging before opening.