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Vivonex Acutrol Enternal Feeding Sys

by Norwich Eaton Pharmaceuticals, Inc.

510(k) K821067

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 NumberK821067 Date29 Apr 1982ClearedStatusActive

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  • Withdrawn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 VIVONEX ACUTROL ENTERNAL FEEDING SYS is a medical device designed for enteral feeding. It is classified under product code KNT and is intended for use in gastroenterology and urology applications.

This device is supplied by Norwich Eaton Pharmaceuticals, Inc. and received FDA 510(k) clearance on April 29, 1982, with K number K821067. The device is substantially equivalent to predicate devices and is regulated under 21 CFR 876.5980.

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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 VIVONEX ACUTROL Enteral Feeding System used for?

    The VIVONEX ACUTROL Enteral Feeding System is a medical device designed for enteral feeding applications specifically in gastroenterology and urology. It is intended to provide nutritional support through the gastrointestinal tract.

  • How is the VIVONEX ACUTROL Enteral Feeding System supplied?

    The VIVONEX ACUTROL Enternal Feeding System is supplied by Norwich Eaton Pharmaceuticals, Inc. The device is manufactured at their facility located at 803 N. Front St. Suite 3, McHenry, IL 60050.

  • What is the regulatory status of the VIVONEX ACUTROL Enteral Feeding System?

    The VIVONEX ACUTROL Enteral Feeding System received FDA 510(k) clearance on April 29, 1982, with K number K821067. It is classified as substantially equivalent to predicate devices and is regulated under 21 CFR 876.5980.

  • What is the product code classification for the VIVONEX ACUTROL Enteral Feeding System?

    The VIVONEX ACUTROL Enteral Feeding System is classified under product code KNT, which indicates its regulatory category and intended use within the FDA's classification system for medical devices.