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Flexiflo Enteral Feeding Tube

by Abbott Laboratories 2 variants

510(k) K832966

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 NumberK832966 Date31 Oct 1983ClearedStatusActive

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  • Withdrawn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
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.

The Flexiflo Enteral Feeding Tube is a nasoenteric feeding tube designed for placement into the stomach or small bowel. It serves as a conduit to facilitate enteral nutrition delivery, ensuring safe and effective feeding support for patients requiring alternative nutritional routes.

This device is supplied in a sterile, single-use configuration and is intended for hospital or clinical settings. The 10FR size and 45" length are standard dimensions for adult use, with packaging containing 10 tubes per case. It holds an FDA 510(k) clearance (K832966) under the Gastroenterology and Urology advisory committee, ensuring compliance with regulatory standards for enteral feeding devices.

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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 purpose of the Flexiflo Enteral Feeding Tube and where is it typically used?

    The Flexiflo Enteral Feeding Tube is designed as a nasoenteric tube to deliver enteral nutrition directly into the stomach or small bowel. It is intended for patients who require alternative nutritional support and is primarily used in hospital or clinical settings where controlled feeding is necessary.

  • Is the Flexiflo Enteral Feeding Tube meant for single-use or can it be reused?

    The Flexiflo Enteral Feeding Tube is supplied in a sterile, single-use configuration, meaning it is intended for one-time use only per patient. Reuse is not recommended or supported by the manufacturer.

  • What are the standard dimensions of the Flexiflo Enteral Feeding Tube, and how is it packaged?

    The standard dimensions for the Flexiflo Enteral Feeding Tube are a 10 French (FR) diameter and a 45-inch length, which are designed for adult use. Each case contains 10 tubes, providing a convenient supply for clinical settings.

  • How is the regulatory status of this device determined, and what committee was involved?

    The Flexiflo Enteral Feeding Tube holds an FDA 510(k) clearance (K832966), which means it was determined to be substantially equivalent to a legally marketed device. The review was conducted under the Gastroenterology and Urology advisory committee, specifically the GU (Gastroenterology, Urology) category.

  • What should I consider regarding storage of the Flexiflo Enteral Feeding Tube before use?

    Since the Flexiflo Enteral Feeding Tube is sterile and single-use, it should be stored in its original packaging until ready for use. Ensure the packaging remains intact and protected from contamination to maintain sterility before opening and deployment.