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Bard Gauderer Universal Percutaneous Endoscopic

FDA 510(k)

Class II (US FDA 510(k))

510(k) K915841

by C. R. Bard, Inc.

Identifiers

510(k) Number
K915841 FDA 510(k)
FDA Product Code
KNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SEKD FDA 510(k)

The Bard Gauderer Universal Percutaneous Endoscopic is a percutaneous endoscopic gastrostomy (PEG) tube, designed for long-term enteral feeding, decompression, or medication administration. It is intended for use in patients requiring gastrointestinal access, providing a reliable conduit for nutritional support or drainage while minimizing trauma to the skin and stomach wall. Constructed as a reusable device, it is classified under product code KNT as a gastrointestinal tube and accessory.

This device is supplied sterile and intended for clinical use in gastroenterology and urology settings, adhering to FDA 510(k) clearance (K915841) under traditional review. It is classified as Class II with special controls, requiring compliance with regulatory standards for gastrointestinal tubes. Sizes and configurations are documented in the original specifications, and proper storage conditions must be maintained to preserve sterility and functionality. No additional regulatory markings beyond the FDA clearance are stated.

Frequently asked questions

Is the Bard Gauderer Universal Percutaneous Endoscopic tube designed for single-use or can it be reused in clinical settings?

The Bard Gauderer Universal Percutaneous Endoscopic tube is explicitly labeled as a reusable device. This classification aligns with its intended use in clinical settings where repeated use is necessary, such as for long-term enteral feeding or decompression. Reusability is supported by its durable construction and compliance with regulatory standards for gastrointestinal tubes.

What clinical specialties would primarily benefit from using this device, and why?

This device is designed for use in gastroenterology and urology settings, as indicated by its advisory committee classification. It provides a percutaneous endoscopic route for gastrointestinal access, making it ideal for patients requiring long-term nutritional support, medication administration, or decompression. Its low-trauma design minimizes skin and stomach wall irritation, which is particularly valuable in these specialties.

How should the Bard Gauderer Universal Percutaneous Endoscopic tube be stored to maintain its sterility and functionality?

The device is supplied sterile, so storage conditions must preserve this sterility while ensuring functionality. While specific storage instructions are not detailed in the provided data, standard practices for sterile reusable medical devices—such as keeping it in a sealed, clean environment away from contaminants—should be followed. Proper storage is critical to prevent degradation and maintain compliance with regulatory standards.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

The Bard Gauderer Universal Percutaneous Endoscopic tube received FDA 510(k) clearance (K915841) under a traditional review process, which means it was compared to a legally marketed predicate device to demonstrate substantial equivalence. This clearance confirms it meets FDA standards for Class II medical devices with special controls, ensuring its safety and effectiveness for long-term gastrointestinal access. Clinicians can rely on this approval for its intended use in enteral feeding, decompression, or medication administration.

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: K915841 - Bard Gauderer Universal Percutaneous Endoscopic, Bard Gauderer Universal Percutaneous Endoscopic, BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC 510 (k) K915841 - FDA ..., K915841 - Bard Gauderer Universal Percutaneous Endoscopic

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) K915841 24 fields · synced Sep 19, 2026