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Flexiflo Enteral Feeding Tube

by Ross Product Div. Abbott Laboratories

510(k) K992494

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 · Special NumberK992494 Date25 Aug 1999ClearedStatusActive

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  • Withdrawn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, 24 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 functions as a conduit for the nasoenteric delivery of nutrition. It may also be used for gastric decompression or the evacuation of gastric contents.

This device is inserted nasally into the stomach or small bowel by healthcare professionals. It is available in a 10FR size with a length of 45 inches and is supplied in quantities of 10 per case. The device has received FDA 510(k) clearance.

Other devices from Ross Product Div. Abbott Laboratories

Questions

AI-generated answers, 24 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 use of the Flexiflo Enteral Feeding Tube?

    This device serves as a conduit for the nasoenteric delivery of nutrition. Additionally, it is indicated for gastric decompression or the evacuation of gastric contents as determined by a healthcare professional.

  • How is the Flexiflo Enteral Feeding Tube supplied?

    The device is available in a 10FR size with a length of 45 inches. It is supplied in quantities of 10 units per case to support clinical inventory requirements.

  • What is the regulatory status of this feeding tube?

    The Flexiflo Enteral Feeding Tube has received FDA 510(k) clearance under K992494, confirming it is substantially equivalent to existing devices for its intended use in gastroenterology.