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Bard Double Pigtail Ureteral Stent

FDA 510(k)

Class II (US FDA 510(k))

510(k) K861478

by C. R. Bard, Inc.

Identifiers

510(k) Number
K861478 FDA 510(k)
FDA Product Code
FAD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4620 FDA 510(k)
Regulation Number
876.4620 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard Double Pigtail Ureteral Stent is a medical device classified as a ureteral stent, designed to relieve obstruction in the ureter. It features a double pigtail configuration to maintain positioning within the urinary tract, promoting patency and drainage while minimizing migration risk.

This device is supplied as a single-use, sterile product and is intended for use in both benign and malignant ureteral obstruction cases. Available in multiple lengths and sizes (e.g., 7FR, 22–32 cm), it includes a hydrophilic coating for ease of insertion and a monofilament suture loop to facilitate removal. The stent adheres to FDA 510(k) clearance (K861478) under regulatory classification 2, with no MRI safety restrictions specified.

Frequently asked questions

What clinical scenarios is the Bard Double Pigtail Ureteral Stent designed to address, and how does its double pigtail design benefit patients?

The Bard Double Pigtail Ureteral Stent is specifically designed to relieve obstruction in the ureter caused by both benign and malignant conditions. The double pigtail configuration helps maintain stable positioning within the urinary tract, reducing the risk of migration while promoting patency and proper drainage. This design is particularly useful in cases where traditional stents may dislodge or cause discomfort during insertion.

Is the Bard Double Pigtail Ureteral Stent intended for single-use or reusable applications, and what features support its usability?

The Bard Double Pigtail Ureteral Stent is supplied as a single-use, sterile product, ensuring patient safety and reducing the risk of cross-contamination. Its hydrophilic coating facilitates easier insertion, while the included monofilament suture loop simplifies removal, making it more convenient for clinicians during procedures.

What sizes and lengths are available for the Bard Double Pigtail Ureteral Stent, and how might this variability benefit different patients?

The stent is available in multiple sizes, including a 7FR diameter, and lengths ranging from 22 cm to 32 cm. This variability allows clinicians to select the appropriate dimensions based on patient anatomy and specific clinical needs, ensuring optimal fit and functionality for both pediatric and adult patients.

How is the Bard Double Pigtail Ureteral Stent regulated, and what does its FDA 510(k) clearance indicate about its safety and effectiveness?

The Bard Double Pigtail Ureteral Stent holds FDA 510(k) clearance under the registration number K861478, classified as substantially equivalent to a predicate device. This clearance indicates that the FDA has determined the device is as safe and effective as a legally marketed alternative, based on clinical data and regulatory review. The clearance was granted under the traditional 510(k) pathway, reviewed by the Gastroenterology and Urology advisory committee.

Are there any special considerations for storage or handling of the Bard Double Pigtail Ureteral Stent before use?

Since the stent is sterile and single-use, it should be stored in its original packaging until ready for use to maintain sterility. The packaging should be kept in a clean, dry environment, away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for opening and handling to ensure the device remains uncontaminated prior to insertion.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: InLay Optima™ Ureteral Stent - BD, Ureteral Stents, Inlay Optima™ - 788628 | BD, C.R. Bard 777700 - STENT, URETERAL, INLAY, 7FR, 22-32CM, EACH, BARD: 778722 - WestCMR

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K861478 24 fields · synced Sep 19, 2026