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Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube

by C. R. Bard, Inc.

510(k) K063118

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063118 Date13 Feb 2007ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNT
FDA applicant
C.R. Bard, Inc.
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a percutaneous gastrostomy kit that includes a balloon dilation catheter and a tri-funnel gastrostomy tube. It is used to establish or maintain a stoma for tube placement through mechanical tissue dilation. The device is non-powered and operated manually.

The kit is supplied as a single-use, sterile system intended for clinical settings where gastrostomy access is required. It is classified under product code KNT as a gastrointestinal tube and accessories, and is regulated as a Class II device with special controls. Storage conditions and specific sizes are not detailed in the available data.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical purpose of this device?

    This device is used to establish or maintain a stoma for gastrostomy tube placement. It achieves access through mechanical tissue dilation using a balloon dilation catheter, and it includes a tri-funnel gastrostomy tube as part of a single integrated kit for percutaneous gastrostomy procedures.

  • How is the device supplied and is it intended for single use?

    The device is supplied as a single-use, sterile system. It is designed for one-time clinical application and should not be reused or re-sterilized, as it is provided pre-sterile and intended for immediate use in a clinical setting.

  • What type of gastrostomy tube is included and what are its design features?

    The kit includes a tri-funnel gastrostomy tube, which features three lumens or channels within the tube structure. This design is typically used to allow for simultaneous feeding, drainage, or medication administration through a single stoma, though specific dimensional details are not provided in the available data.

  • What regulatory classification and product code applies to this device?

    This device is classified under product code KNT as a gastrointestinal tube and accessories. It is regulated as a Class II medical device with special controls, and it was reviewed under the FDA 510(k) premarket notification process with a traditional clearance pathway.

  • What storage conditions should be followed for this device?

    Specific storage conditions are not detailed in the available device data. As a sterile, single-use system, it should be stored in a dry, cool environment away from direct sunlight and extreme temperatures until the time of use, following standard sterile supply practices.